EP1956973B1 - Electro-mechanical connector for thin medical monitoring patch - Google Patents
Electro-mechanical connector for thin medical monitoring patch Download PDFInfo
- Publication number
- EP1956973B1 EP1956973B1 EP06821260.4A EP06821260A EP1956973B1 EP 1956973 B1 EP1956973 B1 EP 1956973B1 EP 06821260 A EP06821260 A EP 06821260A EP 1956973 B1 EP1956973 B1 EP 1956973B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- patch
- connector
- contacts
- clip
- electrical
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/25—Bioelectric electrodes therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6832—Means for maintaining contact with the body using adhesives
- A61B5/6833—Adhesive patches
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
- H01R13/02—Contact members
- H01R13/22—Contacts for co-operating by abutting
- H01R13/24—Contacts for co-operating by abutting resilient; resiliently-mounted
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
- H01R13/46—Bases; Cases
- H01R13/52—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases
- H01R13/5224—Dustproof, splashproof, drip-proof, waterproof, or flameproof cases for medical use
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
- A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
- A61B2560/0412—Low-profile patch shaped housings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/22—Arrangements of medical sensors with cables or leads; Connectors or couplings specifically adapted for medical sensors
- A61B2562/225—Connectors or couplings
- A61B2562/227—Sensors with electrical connectors
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01R—ELECTRICALLY-CONDUCTIVE CONNECTIONS; STRUCTURAL ASSOCIATIONS OF A PLURALITY OF MUTUALLY-INSULATED ELECTRICAL CONNECTING ELEMENTS; COUPLING DEVICES; CURRENT COLLECTORS
- H01R13/00—Details of coupling devices of the kinds covered by groups H01R12/70 or H01R24/00 - H01R33/00
- H01R13/02—Contact members
- H01R13/22—Contacts for co-operating by abutting
- H01R13/24—Contacts for co-operating by abutting resilient; resiliently-mounted
- H01R13/2407—Contacts for co-operating by abutting resilient; resiliently-mounted characterized by the resilient means
- H01R13/2421—Contacts for co-operating by abutting resilient; resiliently-mounted characterized by the resilient means using coil springs
Definitions
- monitoring and therapy devices are attached to the patient's skin to observe and monitor patient conditions such as health, blood flow, heart rhythm, blood oxygen levels, administer therapy as required, and the like.
- monitoring and therapy devices include the electrocardiograph to monitor ECG, external defibrillators, pacing devices, transcutaneous nerve stimulation devices, and transdermal drug delivery systems.
- devices are attached for extended periods of time and must be removed prior to showering, or when changing clothes.
- Many of the monitoring devices are large and typically are worn on a belt with wires attached to skin-mounted, disposable electrodes. The larger devices are uncomfortable to carry. Movement of the wires, monitoring device, or electrodes due to the attachment of wires may create artifacts in the monitored waveform.
- Another approach is to use smaller external devices which are typically held in place with medical grade tape completely covering the device.
- Such method of skin attachment provides a secure and water-resistant adhesion to the skin, but does not allow the skin to breath or move under the device.
- Body moisture accumulates in occluded areas which aggravates the skin.
- Skin held rigidly under a device is affected by movements of the device. This creates artifact in the monitored waveforms. Rigidly held skin may also become irritated, especially at the tape-to-skin boundary.
- the constant pressure of the device against the skin may also cause depressions in the skin, which become irritating.
- US2004/0077954 A1 discloses a monitor with cardiac and movement sensors that are responsive to a user's heart beat and a user's movement.
- the monitor is disc-shaped and its rear comprises a recessed clip which is removably attachable to an electrical contact of a conventional ECG electrode.
- US6456872 B1 discloses a Holter-type apparatus for the recording of physiological signals indicative of cardiac activity.
- the apparatus has a base unit formed of a flexible sheet carrying the electrodes collecting the physiological signals and the conductive connection elements connected to the electrodes.
- the base unit has a central area receiving a recording case and which contains contact areas forming the proximal terminations of the respective conductive connection elements.
- the recording case is equipped to be fastened to the base unit central area and to have electrode contacts that make electrical contact with contact areas of the base unit.
- the base unit also can carry a battery to supply power to the recording case.
- the base unit is advantageously made of a sheet of flexible printed circuit material carrying a conducting pattern forming the aforementioned electrodes, conductive connection elements and contact areas.
- US6603995 B1 discloses a portable ECG monitoring apparatus comprising a sensor device detachable from a monitoring device 2.
- the sensor device includes ECG sensors attached via cabling to a connector.
- the sensor device and monitoring device are connected by attaching the connector to the monitoring device, which provides a watertight seal for the apparatus and prevents access to any internal components in the monitoring device.
- US5458124A discloses a wireless transmitter module for use in a system for monitoring at least one physiological condition of a subject.
- the transmitter module includes a housing and an electrode patch preferably having three closely spaced electrodes provided on a first surface thereof.
- the first surface of the patch is coated with a non-allergenic adhesive in regions surrounding the electrodes, whereby the patch is securable to the subject by the adhesive to permit sensing of a physiological signal of the subject by the electrodes.
- the module has snaps for detachably connecting the electrode patch to the exterior of the housing, the snaps being operable to effect electrical communication of the electrodes with the circuitry when the electrode patch is connected to the housing, whereby the entirety of the transmitter module is supported by the electrode patch when the electrode patch is connected to the housing and the first surface is adhered to the subject.
- US 5249576 A relates to a pulse oximeter probe, in which a sensor has a pin and socket mechanical configuration.
- a rectangular element consisting of anisotropically conducting elastomer which provides electrical conductivity only in the thickness dimension thereof is included in the sensor connector.
- the present invention provides new and improved apparatuses and methods which overcome the above -referenced problems and others.
- the invention is defined by the independent claims.
- Features of further advantageous embodiments of the invention are defined in the dependent claims.
- the medical device includes device electrical contacts.
- a patch includes a conductive first layer, which is in direct electrical communication with skin.
- a patch connector which includes electrical contacts in electrical communication with the first conductive layer, establishes an electrical communication path between the skin and medical device contacts and affixes the medical device in close proximity to the patch.
- a patch which includes a conductive first layer, is disposed in direct electrical communication with the base surface.
- the patch is electro mechanically connected to a medical device connection interface which includes a first connector and device contacts.
- a connector which comprises a clip.
- the clip includes a first surface; a second surface opposite the first surface; extending portions disposed on the first surface; and a band of elastomeric material which extends from about the first surface to about the second surface to electrically contact device contacts of a monitoring device on the first surface and patch contacts on the second surface when the extending portions engage with a case of the medical device.
- the invention may take form in various components and arrangements of components, and in various steps and arrangements of steps.
- the drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention.
- a modular device 8 includes a monitoring or therapy or other medical device 10 which is attached to a patient 12 via a patch assembly 14.
- the patch assembly 14 provides a communication path between the monitoring device 10 and a base surface or skin 18 of the patient 12 in one or more areas 20 .
- the patch assembly 14 includes a patch or patch laminate 22 including a plurality of layers 24 and an electromechanical connector or connection interface 26.
- a thickness d of the electromechanical interface 26 is less than 10mm.
- medical devices 10 are cardiac ECG event monitors, ECG Holter recorders, and cardiac emergency alerting devices.
- a first conductive material layer or pieces of first conductive material or first electrodes 28, such as conductive hydrogel, are disposed at a proximate or first surface 30 of the patch assembly 14 to make direct contact with the skin 18 .
- a second layer or electrodes or patch circuit layer 32 is disposed proximately to a top surface 34 of the first conductive hydrogel layer 28.
- the second electrodes 32 are constructed from silver/silver chloride (Ag/AgCl) or from any other suitable material.
- the electrodes 32 are disposed in communication with the skin 18 to measure the voltage difference between two or more locations on the body. Although only two patch contacts 32 are illustrated, it is contemplated that a number of contacts may be greater than two.
- the monitoring device 10 includes a connection interface 36.
- the patch connector 26 is disposed proximately to the monitoring device 10 at a connector first or top layer or surface 38 and to the patch assembly 14 at a connector second or bottom layer or surface 40. Ionic conduction from the skin 18 passes through the first conductive or hydrogel material layer 28 , changes to electronic conduction in the circuit layer 32 and as such is passed to the monitoring or therapy device 10 via electrical contacts or connection interface 42 of the electromechanical connector 26 .
- the patch connector 26 is a stand alone connector which is disposed between the monitoring device 10 and the patch laminate 22 .
- the patch connector 26 includes connection interfaces disposed throughout the patch layers 24 .
- the connector 26 includes a rigid base layer 44 and/or a mechanical member or members 47 to establish a rigid mechanical connection between the patch 22 and the monitoring device 10.
- the first conductive hydrogel layer 28 improves the electrical conductivity between the electrodes 32 and the skin 18.
- Typical components of a conductive hydrogel include water, which acts as the solvent, water-soluble monomers, which crosslink to give structure to the gel and which may also provide skin adhesion, humectant materials which reduce the dryout characteristics of the hydrogel material, and electrolytes or salts such as sodium chloride or potassium chloride dissolved in water, which provide and facilitate ionic movement and conductivity.
- water acts as the solvent
- water-soluble monomers which crosslink to give structure to the gel and which may also provide skin adhesion
- humectant materials which reduce the dryout characteristics of the hydrogel material
- electrolytes or salts such as sodium chloride or potassium chloride dissolved in water, which provide and facilitate ionic movement and conductivity.
- the electromechanical connector 26 provides the electrical connections between the patch circuit layer 32, which is in electrical contact with the skin 18 via the first conductive layer 28, and the monitoring or therapy device 10.
- the electrical connections may either be low impedance connections, such as a pin-to-metal pad connection, or high impedance connections, such as a higher-impedance conductive silicone to metal pad connection.
- the electromechanical connector 26 also provides the mechanical connection to the monitoring device 10 via a monitoring, device connection interface or second or device connector 46.
- Electrical artifacts include artifacts due to common mode voltages and electrostatic charges that affect the skin, electrode patch and monitoring device.
- Motion artifacts include voltages produced by the skin, fat and muscle during skin stretching under the electrodes, movement of the electrode or sensor on the skin, intermittent electrode or sensor contact with the skin, wire movement, and movement of the monitoring or therapy device which translates to movement of electrodes or sensors on the skin.
- light sensors are also subject to artifact from external light sources.
- Rigid mechanical connections can drive the artifact frequency band higher, while, looser, floppy mechanical connections can dampen artifacts and drive the artifacts to a lower frequency.
- Rigid patch materials may hold the skin tighter and reduce the amplitude of artifacts caused by skin and muscle stretching. Decoupling the electrodes from each other and from the monitoring or therapy device may decrease the affect of device movement on the electrodes.
- the patch connector 26 provides low impedance electrical connection of the patch assembly 14 to the medical device 10. More specifically, the electrical contacts 42 of the patch connector 26 include snaps 48 which connect to device contacts 50 which are disposed about a bottom surface 52 of the monitoring device 10. The snaps 48 provide electrical and mechanical connection of the patch assembly 14 to the monitoring device 10. More specifically, each snap 48 includes a snap top 54 and a snap eyelet 56. Each snap top 54 includes a snap post 58 which is inserted into respective matching snap receptacle (not shown) in the monitoring device 10 to hold the snaps 48 rigidly in place. Three, four, five, six or more snaps 48 form a stabilizing plane to hold the monitoring device 10 rigidly against the patch assembly 14 and distally from the base surface or skin 18.
- Each snap top 54 connects with respective snap eyelet 56 through corresponding openings 60 in a retention seal layer 62, and openings 64 in a snap support layer 66 to establish electrical contact.
- the retention seal layer 62 protects the hydrogel layer 28 from outside water entry; while the snap sealing layer 66 prevents the snaps 48 from tearing out of the patch assembly 14.
- the snap sealing layer 66 is constructed from polyester or other appropriate stiff supporting material.
- the snap eyelets 56 are constructed from a conductive material.
- each snap eyelet 56 is coated with a conductive material such as silver/silver chloride to provide low offset and low noise body signal (ECG or other) measurements.
- a first face or side 70 of each snap eyelet 56 makes contact with the first conductive layer 28 such as pieces of hydrogel material which make contact with the base surface or skin 18 .
- the first pieces of hydrogel material 28 are disposed in a hydrocolloid or frame layer 72
- a non-conductive liquid-proof sealing layer 78 between the monitoring device 10 and the patch assembly 14 surrounds the snaps 48 to provide additional protection for the snaps 48 from outside liquids such as shower water.
- the sealing layer 78 includes a single, compressible, elastomer gasket that is bonded to a top surface 80 of the retention seal layer 62 which compresses when the monitoring device 10 snaps onto the snaps 48.
- the height of the uncompressed gasket is greater than the snap posts 58 . The gasket compresses and creates the seal as the snaps mate with the respective mating receptacles. Individual discrete seals may be used around each snap 48 in place of the single elastomer gasket.
- the patch assembly 14 in this embodiment includes the patch connector 26 which is a molded connector which includes individual connector contacts 42 such as individual pogo-style spring-loaded pins 80 to provide a low impedance connection.
- the pins 80 are post-inserted or insert molded into the connector through the top or first surface 38 of the connector 26 (as seen in FIGURE 3B ) to allow the spring-loaded end of each pin 80 to extend through the second or bottom surface 40 of the connector 26 into a sealing boss 86.
- the sealing boss 86 is drafted inwards to provide mechanical locking feature for mechanical connection with the monitoring device 10. More specifically, a top surface of the sealing boss 86 which is distal from the bottom surface 40 of the connector 26 is larger than a rear surface of the sealing boss 86 which is proximate to the bottom surface 40 of the connector 26.
- a non-conductive elastomeric sealing boot 90 which includes an opening 92 with ribbed walls 94 in a central portion, is connected to the connector 26. More specifically, when the connector 26 and the sealing boot 90 are mated, the rigid sealing boss 86 pushes through the ribbed walls 94 of the center opening 92 of the sealing boot 90, compressing the elastomer material and creating radial force which holds the patch 22 via the boot 90 onto the connector 26. To reinforce, the inward draft on the walls of the sealing boss 86 prevents the sealing boot 90 from sliding off.
- outside walls 96 of the sealing boot 90 include ribs 98 which compress and deflect against the inner walls of the connector 26 to form a seal against outside moisture entry into the boss 86 of connector 26 .
- the spring-loaded pins 80 contact metal pads or traces provided on the patch circuit layer 32 of the patch 22.
- the pads or traces lead to the first individual conductive pieces 28 and carry signals from the first pieces 28 to the monitoring device 10 and from the monitoring device 10 to the first pieces 28.
- the pads and traces may be printed using silver, silver/silver chloride, or conductive carbon ink on a polyester or PVDF substrate.
- the pads and traces may be plated copper traces on a flexible polyester or Kapton substrate.
- the pads and traces may be part of a printed circuit board.
- the electrical contacts 42 of the patch connector 26 of this embodiment include a connector printed circuit layer or board 102 , which is bonded to the retention seal layer 62 via a diecut piece of a non-conductive pressure sensitive adhesive layer (PSA) 104 .
- the retention seal layer 62 and pressure sensitive adhesive layer 104 include respective openings 60 , 106 to be filled with conductive epoxy 107 which electrically connects the patch circuit layer 32 to conductive pads 108 disposed on the printed circuit board 102. More specifically, during the assembly, the pressure sensitive adhesive layer 104 is aligned over printed circuit pads 110 on the patch circuit layer 32, which for example is, a printed polyester layer, and adhered to the retention seal layer 62.
- Each of the openings 106 in the PSA layer 104 is filled with conductive epoxy.
- the connector printed circuit board 102 is aligned with the PSA layer 104 .
- the entire patch assembly 14 is placed in a heated chamber to hasten the cure of the conductive epoxy.
- the conductive epoxy may be allowed to cure at room temperature as the patch assembly 14 is packaged and shipped.
- the top surface 38 of the connector 26 includes a multipin straight connector or right angle header with or without a housing snap which enables the electromechanical attachment of the patch assembly 14 to the monitoring device 10.
- the sealing gasket is bonded to the top surface 38 of the connector 26. Upon insertion of the connector 26 into the monitoring device 10, the gasket compresses to protect the connector pins from liquid entry.
- the patch connector electrical connection interface 42 includes a single piece or layer 112 of Z-axis conductive pressure sensitive adhesive (PSA), which directly electrically connects the patch electrodes 32 to the device contacts 50 on the bottom surface 52 of the monitoring device 10.
- PSA Z-axis conductive pressure sensitive adhesive
- the Z-axis conductive PSA is pressed between the top surface 38 of the patch assembly 14 and the bottom surface 52 of the monitoring device 10 with a sufficient amount of pressure for a sufficient amount of time, which is specific to the individual material. For example, a pressure of 30 PSI which is applied for 5 seconds may be sufficient for 3M 9703TM, but may not be sufficient for a different PSA.
- Many conductive PSA materials are not suitable for use alone as structural PSA layers.
- a strengthening, non-conductive PSA layer is applied around such conductive PSA to improve strength and support, and to bring the Z-axis conductive PSA into compression which provides a more consistent electrical connection.
- the patch assembly connector 26 of this embodiment includes a clip 114.
- the clip 114 includes the top surface 38 proximate the monitoring device 10, bottom surface 40 proximate the patch 22 and the connector printed circuit layer 102, such as a flexible circuit layer, which mates with the patch circuit layer 32, which, in this embodiment, is a flexible circuit layer disposed between first and second dielectric layers 116, 118.
- the connector flexible circuit layer 102 is aligned so that its traces mate with respective traces of the patch circuit layer 32.
- a low-impedance Z-axis conductive adhesive is applied to the connector flexible circuit 102 which bonds the connector printed circuit 102 to the patch circuit 32 and electrically connects the traces.
- the clip 114 includes a non-conductive layer of pressure sensitive adhesive 119 which bonds the clip 114 to the patch 22 mechanically and structurally.
- the clip non-conductive PSA layer 119 provides the liquid-proof seal between the clip 114 and the patch 22.
- a tongue or extending portion 120 of the clip 114 is inserted into a slot 122 of a case 124 the monitoring device 10. Once inside the monitoring device 10, the traces on the bottom surface of the clip tongue 120 mate with the device contacts 50 in the monitoring device 10. This completes the electrical circuit between the patch traces and the monitoring device 10.
- the monitoring device 10 snaps completely into the clip 114, which is, for example, a snap action clip.
- the device contacts 50 such as pins and leaf springs, on the bottom surface 52 of the monitoring device 10 connect electrically with corresponding patch metal contacts 42, i.e., gold-plating over nickel-plated copper pins, or the connector printed circuit board 102 of the clip 114 through a single piece of thin, Z-axis conductive elastomer sheet 126.
- the elastomer sheet 126 compresses as the clip 114 snaps onto the monitoring device 10.
- the conductive particles i.e.
- the patch 22 is attached to the clip 114 with one or more pieces of pressure sensitive adhesive.
- a conductive adhesive such as 3M 9703TM, can be used to make the electrical connection between the patch traces and the metal contacts in the clip 114.
- a piece of non-conductive structural adhesive may be used around the conductive PSA layer to improve the strength and reliability of the bond between the patch 22 and clip 114.
- the clip 114 includes one or more extending portions 120 which are inserted through the patch circuit layer 32.
- the clip 114 is held in place by the frame layer 72.
- the patch connector electrical connection interface 42 includes the layer 126 of a Z-axis conductive elastomer material which provides electrical connection between the monitoring device 10 and the patch circuit layer 32.
- the patch traces are directly exposed to the Z-axis conductive silicone layer 126, which electrically connects the patch traces to the device contacts 50 on the bottom surface 52 of the monitoring device 10.
- Such direct connection is more reliable and robust, since every additional electrical interface increases the risk for the patch failure.
- the clip 114 By passing under and through the patch circuit 32 and mechanically by snap action connecting with the monitor 10, the clip 114 provides a rigid support surface against which the monitoring device 10 may press into the patch traces. The rigid surface provides a more consistent pressure between the monitoring device and patch contacts.
- the device contacts 50 of the monitoring device 10 include pins which make direct contact with the patch circuit layer 32.
- the monitoring device pins 50 each includes a shoulder 128, which tapers to a point near the end.
- the pins 50 press through or make openings 130, 132 in respective first or top and second or bottom layers 134, 136 of a non-conductive elastomer.
- the top layer openings 130 have smaller diameter than the bottom layer openings 132. Further, the diameter of each top layer opening 130 is smaller than the dimensional measurements of the shoulder 128 of the pins 50 .
- the top layer opening 130 traps respective shoulder 128 of each pin 50 once the pins are pressed through the openings 130, 132 and force the pins 50 to contact exposed pads or traces on the patch circuit layer 32.
- the patch connector electrical connection interface 42 includes a single band of higher-impedance Z-axis conductive elastomer 140, such as silicone, surrounded by a single, conductive or non-conductive elastic seal 142.
- the conductive silicone 140 When compressed, the conductive silicone 140 provides electrical connection between the device contacts 50 on the bottom surface 52 of the monitoring device 10 and conductive traces on the patch 22 .
- the conductive silicone 140 can be inserted or over-molded to pass completely through the clip 114 and make contact with the monitoring device 10 on the clip top surface 38 and the conductive traces or pads of the patch 22 on the clip bottom surface 40. E.g., no additional clip contacts are required.
- non-conductive PSA may be used to bond the patch layers to the clip 114.
- the device contacts 50 of the monitoring device 10 are shown to be flush with the bottom surface 52 of the monitoring device 10, it is contemplated that the device contacts 50 of the monitoring device 10 can extend beyond the bottom surface 52 of the monitoring device 10 or be recessed into the bottom surface 52 of the monitoring device 10.
- the clip extensions 120 releasably engage the case 124 of the medical device 10 to hold the medical device 10 and the patch 22 together.
- the patch traces may be backed up with another material, such as a thicker, firmer material, e.g. 0.032 inch-thick polyethylene foam.
- the elastic seal 142 surrounds the single piece or array of conductive silicone element(s) and, when compressed against the base of the monitoring device, prevents liquid entry into the contact area.
- First alignment structures or means 144 disposed on the first clip surface 38 mate with second alignment structures or means 146 disposed on the bottom surface 52 of the monitoring device 10 so that the connector electrical contacts 42 are aligned with the device contacts 50.
- pin-type alignment structures are shown, other alignment structures may be employed, such as mated notches and tongues along the periphery of the clip surfaces.
- the medical device 10 and clip 114 may be asymmetrically shaped such that device 10 insertion can be accomplished in only one orientation into clip 114.
- individual conductive silicone contacts are overmolded or post-inserted into the rigid clip 114 in place of a single piece of z-axis conductive elastomer 140.
- the individual contacts can also be co-molded into a single connector or subassembly part using a non-conductive elastomer or polymer to bridge the gap between each contact.
- the bottom surface of the contacts may be printed or otherwise coated with conductive ink.
- a piece of Z-axis conductive adhesive may be laminated between the patch and the clip contacts, inside a window in the surrounding structural pressure sensitive adhesive
- the rigid clip 114 mechanically attaches the patch 22 to the monitoring device 10.
- the clip electrical contacts 42 include individual pieces or contacts 150 of the conductive elastomer, such as conductive silicone, which electrically connect the patch traces to the device contacts 50 on the bottom surface 52 of the monitoring device 10 .
- Each individual conductive silicone piece 150 is surrounded by an elastomer seal 152. Such individual seals allow the individual pieces of silicon to maintain isolation from each other even if one seal fails.
- the elastomer contacts 150 are molded or inserted partway into the clip 114.
- the clip electrical contacts 42 further include silver/silver chloride (Ag/AgCl) plated plugs 154 which are insert-molded or post-inserted or applied into the bottom surface 40 of the clip 114 through openings 156 to make contact with each respective conductive elastomer contact 150 and the first hydrogel layer 28 of the patch 22.
- silver/silver chloride (Ag/AgCl) plated plugs 154 which are insert-molded or post-inserted or applied into the bottom surface 40 of the clip 114 through openings 156 to make contact with each respective conductive elastomer contact 150 and the first hydrogel layer 28 of the patch 22.
- the plug 154 is constructed from a conductive metal or plastic, such as a glass-fiber reinforced conductive acrylonitrile butadiene styrene (ABS), that is molded into shape. It is contemplated that the plug may or may not include a flange for touching the gel, and a post for press-fitting into the clip. The formed or molded plug is plated with the Ag/AgCl before or after molding.
- ABS glass-fiber reinforced conductive acrylonitrile butadiene styrene
- the plug 154 can be die cut from a thin sheet of metal or conductive polymer, and then plated with the Ag/AgCl.
- the clip 114 is similar to the clip of the embodiments described above, except the Ag/AgCl plugs 154 are omitted.
- the pieces 150 of the conductive elastomer material are overmolded through the entire thickness of the clip 114 so that the pieces 150 extend out or are flush with both the top and bottom surfaces 38, 40 of the clip 114.
- the exposed bottom surface 40 makes contact with metal traces or contacts of the patch 22, while the top surface 38 is exposed for contact with the device contacts 50 of the monitoring device 10 .
- each piece 150 of the elastomer material such as silicone
- the surface of each piece 150 of the elastomer material is pad printed or screen-printed with a Ag/AgCl ink to make contact with the first conductive hydrogel layer 28 to form a half-cell reaction.
- the ink may be formulated in a silicone base.
- the pieces of the conductive silicone are loaded with Ag/AgCl particles.
- the Ag/AgCl particles may be the conductive material in the silicone. If the loading is of high concentration, the Ag/AgCl particles in the cured silicone will form an adequate half-cell reaction as at the contact with the hydrogel.
- the clip 114 includes clip openings 160.
- the clip electrical contacts 42 include rings 162 of Ag/AgCl which are pad or screen printed directly to the bottom surface 40 of the clip 114 to surround each clip opening 160.
- the clip electrical contacts 42 further include conductive silicone 164 which is overmolded completely through the openings 160 to overlap a portion of the printed Ag/AgCl rings 162 on the bottom surface 40 which contacts the patch 22.
- the rings 162 of Ag/AgCl create the half-cell reaction.
- the conductive silicone 164 which overlaps each printed ring 162 conducts the body signals to the contacts of the monitoring device 10.
- a vacuum is used to draw the Ag/AgCl ink inside the clip openings 160.
- the conductive silicone does not need to flow all the way through the clip opening 160 since the contact with the Ag/AgCl is made inside the clip opening 160.
- the device contacts 50 include reusable conductive posts which are molded or inserted into the bottom housing of the monitoring device 10 to make direct contact with the hydrogel layer 28 of the patch assembly 14 .
- such posts are formed of metal or molded of conductive polymer.
- the posts are plated with Ag/AgCl before being inserted into the housing of the monitoring device 10. Since the posts can be cleaned between each application of the patch 22 to the patient, the Ag/AgCl coating should be thick and robust enough to withstand multiple cleanings and patch applications.
- the posts may be sintered out of Ag/AgCl. This eliminates plating the posts afterwards, and ensures that Ag/AgCl is not taken off the posts.
- the patch 22 may be mechanically attached to the monitoring device 10 in several ways.
- the patch 22 is attached to the monitoring device 10 with the clip 114, which is bonded to the patch 22 with a non-conductive PSA layer 165 .
- the posts or device contacts 50 pass through the patch layers 24 and touch the first hydrogel layer 28 directly.
- Individual protective O-rings 168 are provided to seal and protect each post from liquid entry during bathing or showering.
- the patch 22 can be attached to the monitoring device 10 via a non-conductive PSA layer, or a multi-layer PSA laminate. Openings are provided in the PSA layer to allow the Ag/AgCl posts to pass through and contact the first hydrogel layer 28 .
- the PSA layer holds the patch 22 to the monitoring device 10 and seals around and between the individual posts.
- a thicker PSA layer, or a thin (20 mil or 32-mil) PE or PU foam with adhesive on both sides may be used in place of the thick PSA. Being compressible, the foam compensates well for variations of Ag/AgCl post protrusion distances. In one embodiment, different adhesives on each side of the foam or PSA layer are used.
- an aggressive PSA layer is used on the patch side and a less aggressive, easier to peal PSA layer, is used on the monitoring device side for the PSA material to come cleanly off of the monitoring device so that the monitoring device 10 can quickly be cleaned and prepared for use with a new patch.
- the direct connection of the silver/silver chloride contacts with the hydrogel layer 28 eliminates conductive traces on the patch 22 and minimizes the number of connections required to make connection between the monitoring device and the base layer, improving reliability and potentially decreasing noise artifact. Without traces, the patch circuit layer 32 can become relatively inexpensive to manufacture. This also increases the material choices available for the circuit layer. For example, thinner polyester or PVDF films may be used if no printing is required. As the thinner films are used, the patch 22 becomes increasingly flexible and comfortable.
- Ag/AgCl is desirable as the hydrogel contact material for monitoring electrodes due to the stability of the resulting half-cell reaction.
- the clip 114 is molded over a part of the patch circuit layer 32 via a technique similar to in-mold decorating techniques. More specifically, in-mold decorating techniques place a pre-formed printed polyester film into the injection mold against the inside surface of the mold. The molten polymer is then shot against the film and cooled. Once cooled, the polyester film is inseparable from the polymer.
- the patch circuit layer 32 is a thin, printed polyester layer, suitable for placement in an injection-molding tool. As one example, the patch circuit 32 may be preformed into a shape. As another example, the patch circuit 32 may nor be preformed into a shape.
- the clip material is injected and cooled against its surface. This creates a strong mechanical bond between the patch circuit 32 and clip 114.
- the clip 114 includes the openings (not shown), which are positioned to communicate with the contact pads (not shown) in the circuit layer 32.
- the clip electrical connection interface 42 includes conductive silicone which is subsequently overmolded into the clip openings to form a robust electrical connection with the patch circuit 32. Non-conductive elastomeric rings may be molded or bonded around each conductive silicone contact for sealing against the surface of the monitoring device 10.
- the clip 114 and circuit sub-assembly is bonded to the patch 22 .
- the foam layer or support layer 72 is coated on both sides with non-conductive PSA material.
- the PSA material connects and seals the patch circuit layer 32 and clip 114 to the foam layer 72.
- the foam layer 72 is attached to the hydrogel pieces 28 and retention seal 62 .
- FIGURE 22 shows the patch circuit 32 proximate to the patch layers 24, with a patch side printed circuit 170 .
- FIGURE 23 shows the patch circuit 32 proximate to the clip 114 with clip side printed contact pads 172.
- FIGURE 24 shows the clip 114 and the patch 22.
- the clip 114 includes clip openings 166 for the monitoring device posts or overmolding of conductive silicone contacts.
- the monitoring device 10 includes sensors 180 which detect body motion such as respirations, footfalls, heart beats and CPR compressions.
- the patch connector 26 is a low-profile electro-mechanical connection that creates a rigid patch area only in the center of the patch, leaving the outer areas of the patch flexible to bend and stretch with the skin. This minimizes the affect of monitor movement on the patch, thus reducing noise artifact due to monitor movement.
- the invention described above can be applied to other fields where electronic devices are attached to be held firmly to the skin to monitor physiologic signals or responses such as cardiac stress testing.
- One example is the athletic training field where electronic devices are worn to monitor performance.
- Other examples include child monitoring, such as for SIDS where a monitor is attached to the child for long periods of time to monitor cardiac and respiration activity, biosignal monitoring to monitor the health of the animals, and transdermal drug delivery systems which monitor certain patient parameters to determine when additional drug is required, how much is required, and the effects of drug dosage.
- the methods and apparatuses described above provide a low-profile method of mechanically attaching the monitoring device to a thin, flexible patch.
- the thin, low-profile connections allow the monitoring device to become closely coupled to the bio-electrode patch enabling motion artifact detection by the monitoring device.
- motion sensors in the monitoring device accelerelerometers or piezo-electric sensors
- the methods and apparatuses described above prevent the monitoring device from directly contacting the skin.
- the methods and apparatuses described above include a low-profile, wire-free method of electrically connecting the patch electrodes to the monitoring device. Eliminating the wires can reduce electrical artifact in the bioelectric signal.
- the methods and apparatuses described above include a method for creating a liquid-proof seal around each patch contact, or around the group of contacts, when the patch is connected to the monitoring device. Sealing between electrodes ensures that shorting does not occur during a shower or spill.
- the methods and apparatuses described can also be implemented without the seals.
- the methods and apparatuses described above include a rigid central portion. Since the monitoring/therapy device is a relatively large mass attached to the skin, small movements or rotations in the device can create large disturbances in the monitored signal. A rigid portion in the center of the connector stabilizes the monitoring/therapy device and helps reduce motion artifact by preventing excess movement and rotation of the device during patient movement. When only the center is rigid, this connection scheme allows the edges of the patch to conform to body contours.
- the methods and apparatuses described above are user friendly in that they may allow single step connections (both the mechanical and electrical connections are accomplished at the same time with the same user action). They can be performed with a single hand, and they do not require or transmit heavy forces to the body. They also allow attaching the monitoring device to the patch before attaching the patch to the skin.
- the methods and apparatuses described above take advantage of the high-impedance patient monitoring electronics in the monitoring device.
- impedances of the monitoring electronics are very high (i.e. Giga-ohm range)
- connector embodiments can be developed which are in the 1000 - 10,000 Ohm range without significantly affecting the monitored signal.
- the impedance attribute of the connector can be either high - 100 - 10,000 Ohm, medium 20-200 Ohm, or low, ⁇ 20 Ohm.
Description
- The following relates to the medical arts. It finds particular application in conjunction with medical monitoring devices and will be described with particular reference thereto. It will be appreciated that the following is also applicable to other medical and non medical devices in medical and non medical fields such as athletic monitoring, animal, child monitoring, electrical stimulation, medication delivery, and the like, in a variety of applications.
- In many biomedical applications, monitoring and therapy devices are attached to the patient's skin to observe and monitor patient conditions such as health, blood flow, heart rhythm, blood oxygen levels, administer therapy as required, and the like. Examples of monitoring and therapy devices include the electrocardiograph to monitor ECG, external defibrillators, pacing devices, transcutaneous nerve stimulation devices, and transdermal drug delivery systems. In some applications, such as monitoring and therapy, devices are attached for extended periods of time and must be removed prior to showering, or when changing clothes. Many of the monitoring devices are large and typically are worn on a belt with wires attached to skin-mounted, disposable electrodes. The larger devices are uncomfortable to carry. Movement of the wires, monitoring device, or electrodes due to the attachment of wires may create artifacts in the monitored waveform.
- Another approach is to use smaller external devices which are typically held in place with medical grade tape completely covering the device. Such method of skin attachment provides a secure and water-resistant adhesion to the skin, but does not allow the skin to breath or move under the device. Body moisture accumulates in occluded areas which aggravates the skin. Skin held rigidly under a device is affected by movements of the device. This creates artifact in the monitored waveforms. Rigidly held skin may also become irritated, especially at the tape-to-skin boundary. In addition, the constant pressure of the device against the skin may also cause depressions in the skin, which become irritating.
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US2004/0077954 A1 discloses a monitor with cardiac and movement sensors that are responsive to a user's heart beat and a user's movement. The monitor is disc-shaped and its rear comprises a recessed clip which is removably attachable to an electrical contact of a conventional ECG electrode. -
US6456872 B1 discloses a Holter-type apparatus for the recording of physiological signals indicative of cardiac activity. The apparatus has a base unit formed of a flexible sheet carrying the electrodes collecting the physiological signals and the conductive connection elements connected to the electrodes. The base unit has a central area receiving a recording case and which contains contact areas forming the proximal terminations of the respective conductive connection elements. The recording case is equipped to be fastened to the base unit central area and to have electrode contacts that make electrical contact with contact areas of the base unit. The base unit also can carry a battery to supply power to the recording case. The base unit is advantageously made of a sheet of flexible printed circuit material carrying a conducting pattern forming the aforementioned electrodes, conductive connection elements and contact areas. -
US6603995 B1 discloses a portable ECG monitoring apparatus comprising a sensor device detachable from a monitoring device 2. The sensor device includes ECG sensors attached via cabling to a connector. The sensor device and monitoring device are connected by attaching the connector to the monitoring device, which provides a watertight seal for the apparatus and prevents access to any internal components in the monitoring device. -
US5458124A discloses a wireless transmitter module for use in a system for monitoring at least one physiological condition of a subject. The transmitter module includes a housing and an electrode patch preferably having three closely spaced electrodes provided on a first surface thereof. The first surface of the patch is coated with a non-allergenic adhesive in regions surrounding the electrodes, whereby the patch is securable to the subject by the adhesive to permit sensing of a physiological signal of the subject by the electrodes. Additionally, the module has snaps for detachably connecting the electrode patch to the exterior of the housing, the snaps being operable to effect electrical communication of the electrodes with the circuitry when the electrode patch is connected to the housing, whereby the entirety of the transmitter module is supported by the electrode patch when the electrode patch is connected to the housing and the first surface is adhered to the subject. -
US 5249576 A relates to a pulse oximeter probe, in which a sensor has a pin and socket mechanical configuration. A rectangular element consisting of anisotropically conducting elastomer which provides electrical conductivity only in the thickness dimension thereof is included in the sensor connector. -
US 6435882 B1 mentions an anisotropic electrically conductive film, andUS 2003/0216662 Almentions a Z-axis-only conductive adhesive. - The present invention provides new and improved apparatuses and methods which overcome the above -referenced problems and others. The invention is defined by the independent claims. Features of further advantageous embodiments of the invention are defined in the dependent claims.
- In embodiments of the modular device, the medical device includes device electrical contacts. A patch includes a conductive first layer, which is in direct electrical communication with skin. A patch connector, which includes electrical contacts in electrical communication with the first conductive layer, establishes an electrical communication path between the skin and medical device contacts and affixes the medical device in close proximity to the patch.
- In embodiments of the method of connecting a medical device to a subject base surface, a patch, which includes a conductive first layer, is disposed in direct electrical communication with the base surface. The patch is electro mechanically connected to a medical device connection interface which includes a first connector and device contacts.
- In accordance with another aspect, a connector is disclosed which comprises a clip. The clip includes a first surface; a second surface opposite the first surface; extending portions disposed on the first surface; and a band of elastomeric material which extends from about the first surface to about the second surface to electrically contact device contacts of a monitoring device on the first surface and patch contacts on the second surface when the extending portions engage with a case of the medical device.
- Still further advantages and benefits of the present invention will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description of the preferred embodiments.
- The invention may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention.
-
FIGURE 1 is a diagrammatic illustration of a modular medical device; -
FIGURE 2 is an expanded view of a patch assembly; -
FIGURE 3A is a perspective view of one face of a connector which includes pins; -
FIGURE 3B is a perspective view of an opposite face of the connector ofFIGURE 3A ; -
FIGURE 4 is a perspective view of a portion of a mechanical interface of connector ofFIGURE 3A ; -
FIGURE 5 is an expanded view of the monitoring device and the patch assembly; -
FIGURE 6 is an expanded view of a patch assembly which includes an electronic board; -
FIGURE 7 is a view of the monitoring device and the patch which are connected via a single piece of Z-axis conductive pressure sensitive adhesive; -
FIGURE 8 is an expanded view of a patch assembly which includes a clip; -
FIGURE 9A is an expanded view of a clip assembly; -
FIGURE 9B is a diagrammatic illustration of the assembled clip ofFIGURE 9A ; -
FIGURES 10A and10B are diagrammatic illustrations of an assembly of the patch assembly ofFIGURE 8 and a monitoring device; -
FIGURES 11A, 11B and 11C are diagrammatic illustrations of the monitoring device which snaps completely into the clip; -
FIGURE 12 is an expanded view of an assembly of the patch assembly, in which a clip is inserted through the patch layers, and a monitoring device; -
FIGURE 13 is an expanded view of an assembly of a patch and a monitoring device; -
FIGURE 14 is a diagrammatic illustration of one side of a clip which includes a single silicon band; -
FIGURE 15 is an expanded view of an assembly of a monitoring device, patch and clip ofFIGURE 14 ; -
FIGURE 16A is a perspective view of one face of a clip; -
FIGURE 16B is a perspective view of an opposite face of the clip ofFIGURE 16A ; -
FIGURE 17A is a perspective view of one side of a clip; -
FIGURE 17B is a perspective view of an opposite side of the clip ofFIGURE 17A ; -
FIGURE 18A is a perspective view of a portion of a clip; -
FIGURE 18B is a perspective view of the clip ofFIGURE 18A with overmolded inserts; -
FIGURE 19 is a diagrammatic illustration of the monitoring device which includes reusable conductive posts; -
FIGURE 20 is an expanded view of an assembly of a patch and a monitoring device ofFIGURE 19 ; -
FIGURE 21 is an expanded view of the clip molded directly onto the circuit layer; -
FIGURE 22 is a perspective view of the patch ofFIGURE 21 with a patch side printed circuit; -
FIGURE 23 is a perspective view of the patch ofFIGURE 21 with a clip side printed contact pads; -
FIGURE 24 is a perspective view of the clip and the patch ofFIGURE 21 ; and -
FIGURE 25 is a perspective view of the assembled clip and patch ofFIGURE 21 . - With reference to
FIGURE 1 , amodular device 8 includes a monitoring or therapy or othermedical device 10 which is attached to apatient 12 via apatch assembly 14. Thepatch assembly 14 provides a communication path between themonitoring device 10 and a base surface orskin 18 of the patient 12 in one ormore areas 20. More specifically, thepatch assembly 14 includes a patch orpatch laminate 22 including a plurality oflayers 24 and an electromechanical connector orconnection interface 26. In one embodiment, a thickness d of theelectromechanical interface 26 is less than 10mm. Examples ofmedical devices 10 are cardiac ECG event monitors, ECG Holter recorders, and cardiac emergency alerting devices. - A first conductive material layer or pieces of first conductive material or
first electrodes 28, such as conductive hydrogel, are disposed at a proximate orfirst surface 30 of thepatch assembly 14 to make direct contact with theskin 18. A second layer or electrodes orpatch circuit layer 32 is disposed proximately to atop surface 34 of the firstconductive hydrogel layer 28. In one example, thesecond electrodes 32 are constructed from silver/silver chloride (Ag/AgCl) or from any other suitable material. In one embodiment, theelectrodes 32 are disposed in communication with theskin 18 to measure the voltage difference between two or more locations on the body. Although only twopatch contacts 32 are illustrated, it is contemplated that a number of contacts may be greater than two. - The
monitoring device 10 includes aconnection interface 36. Thepatch connector 26 is disposed proximately to themonitoring device 10 at a connector first or top layer orsurface 38 and to thepatch assembly 14 at a connector second or bottom layer orsurface 40. Ionic conduction from theskin 18 passes through the first conductive orhydrogel material layer 28, changes to electronic conduction in thecircuit layer 32 and as such is passed to the monitoring ortherapy device 10 via electrical contacts orconnection interface 42 of theelectromechanical connector 26. As discussed in detail below, in one embodiment, thepatch connector 26 is a stand alone connector which is disposed between themonitoring device 10 and thepatch laminate 22. In one embodiment, thepatch connector 26 includes connection interfaces disposed throughout the patch layers 24. In one embodiment, theconnector 26 includes arigid base layer 44 and/or a mechanical member ormembers 47 to establish a rigid mechanical connection between thepatch 22 and themonitoring device 10. - The first
conductive hydrogel layer 28 improves the electrical conductivity between theelectrodes 32 and theskin 18. Typical components of a conductive hydrogel include water, which acts as the solvent, water-soluble monomers, which crosslink to give structure to the gel and which may also provide skin adhesion, humectant materials which reduce the dryout characteristics of the hydrogel material, and electrolytes or salts such as sodium chloride or potassium chloride dissolved in water, which provide and facilitate ionic movement and conductivity. One advantage of hydrogel materials over other conductive electrolytes is that the hydrogel material can be removed cleanly from the skin without leaving a residue - The
electromechanical connector 26 provides the electrical connections between thepatch circuit layer 32, which is in electrical contact with theskin 18 via the firstconductive layer 28, and the monitoring ortherapy device 10. The electrical connections may either be low impedance connections, such as a pin-to-metal pad connection, or high impedance connections, such as a higher-impedance conductive silicone to metal pad connection. Theelectromechanical connector 26 also provides the mechanical connection to themonitoring device 10 via a monitoring, device connection interface or second ordevice connector 46. The methods of mechanical connection as well as the type of electrical connection, either high or low impedance, play a role in reducing artifact in the monitored signal as described below. - Electrical artifacts include artifacts due to common mode voltages and electrostatic charges that affect the skin, electrode patch and monitoring device. Motion artifacts include voltages produced by the skin, fat and muscle during skin stretching under the electrodes, movement of the electrode or sensor on the skin, intermittent electrode or sensor contact with the skin, wire movement, and movement of the monitoring or therapy device which translates to movement of electrodes or sensors on the skin. In addition, light sensors are also subject to artifact from external light sources.
- Rigid mechanical connections can drive the artifact frequency band higher, while, looser, floppy mechanical connections can dampen artifacts and drive the artifacts to a lower frequency. Rigid patch materials may hold the skin tighter and reduce the amplitude of artifacts caused by skin and muscle stretching. Decoupling the electrodes from each other and from the monitoring or therapy device may decrease the affect of device movement on the electrodes.
- With continuing reference to
FIGURE 1 and further reference toFIGURE 2 , thesecond electrodes 32 are omitted. Thepatch connector 26 provides low impedance electrical connection of thepatch assembly 14 to themedical device 10. More specifically, theelectrical contacts 42 of thepatch connector 26 includesnaps 48 which connect todevice contacts 50 which are disposed about abottom surface 52 of themonitoring device 10. Thesnaps 48 provide electrical and mechanical connection of thepatch assembly 14 to themonitoring device 10. More specifically, eachsnap 48 includes a snap top 54 and asnap eyelet 56. Each snap top 54 includes asnap post 58 which is inserted into respective matching snap receptacle (not shown) in themonitoring device 10 to hold thesnaps 48 rigidly in place. Three, four, five, six ormore snaps 48 form a stabilizing plane to hold themonitoring device 10 rigidly against thepatch assembly 14 and distally from the base surface orskin 18. - Each snap top 54 connects with
respective snap eyelet 56 through correspondingopenings 60 in aretention seal layer 62, andopenings 64 in asnap support layer 66 to establish electrical contact. Theretention seal layer 62 protects thehydrogel layer 28 from outside water entry; while thesnap sealing layer 66 prevents thesnaps 48 from tearing out of thepatch assembly 14. Thesnap sealing layer 66 is constructed from polyester or other appropriate stiff supporting material. In one embodiment, the snap eyelets 56 are constructed from a conductive material. In another embodiment, eachsnap eyelet 56 is coated with a conductive material such as silver/silver chloride to provide low offset and low noise body signal (ECG or other) measurements. A first face orside 70 of eachsnap eyelet 56 makes contact with the firstconductive layer 28 such as pieces of hydrogel material which make contact with the base surface orskin 18. The first pieces ofhydrogel material 28 are disposed in a hydrocolloid orframe layer 72 - A non-conductive liquid-
proof sealing layer 78 between themonitoring device 10 and thepatch assembly 14 surrounds thesnaps 48 to provide additional protection for thesnaps 48 from outside liquids such as shower water. In one embodiment, thesealing layer 78 includes a single, compressible, elastomer gasket that is bonded to atop surface 80 of theretention seal layer 62 which compresses when themonitoring device 10 snaps onto thesnaps 48. In one embodiment, the height of the uncompressed gasket is greater than the snap posts 58. The gasket compresses and creates the seal as the snaps mate with the respective mating receptacles. Individual discrete seals may be used around eachsnap 48 in place of the single elastomer gasket. - With continuing reference to
FIGURE 1 and further reference toFIGURES 3A and 3B , thepatch assembly 14 in this embodiment includes thepatch connector 26 which is a molded connector which includesindividual connector contacts 42 such as individual pogo-style spring-loadedpins 80 to provide a low impedance connection. Thepins 80 are post-inserted or insert molded into the connector through the top orfirst surface 38 of the connector 26 (as seen inFIGURE 3B ) to allow the spring-loaded end of eachpin 80 to extend through the second orbottom surface 40 of theconnector 26 into a sealingboss 86. The sealingboss 86 is drafted inwards to provide mechanical locking feature for mechanical connection with themonitoring device 10. More specifically, a top surface of the sealingboss 86 which is distal from thebottom surface 40 of theconnector 26 is larger than a rear surface of the sealingboss 86 which is proximate to thebottom surface 40 of theconnector 26. - With continuing reference to
FIGURES 3A and 3B and further reference toFIGURES 4 and5 , a non-conductiveelastomeric sealing boot 90, which includes anopening 92 with ribbedwalls 94 in a central portion, is connected to theconnector 26. More specifically, when theconnector 26 and the sealingboot 90 are mated, therigid sealing boss 86 pushes through theribbed walls 94 of the center opening 92 of the sealingboot 90, compressing the elastomer material and creating radial force which holds thepatch 22 via theboot 90 onto theconnector 26. To reinforce, the inward draft on the walls of the sealingboss 86 prevents the sealingboot 90 from sliding off. Since the compressed elastomer wants to relax, the effect of the inward draft causes theboot 90 to slide inward, towards the inside of theconnector 26, further trapping and holding theboot 90 and thepatch 22 against theconnector 26. Outsidewalls 96 of the sealingboot 90 includeribs 98 which compress and deflect against the inner walls of theconnector 26 to form a seal against outside moisture entry into theboss 86 ofconnector 26. - Once the sealing
boot 90 is mated with theconnector 26, the spring-loadedpins 80 contact metal pads or traces provided on thepatch circuit layer 32 of thepatch 22. The pads or traces lead to the first individualconductive pieces 28 and carry signals from thefirst pieces 28 to themonitoring device 10 and from themonitoring device 10 to thefirst pieces 28. For example, the pads and traces may be printed using silver, silver/silver chloride, or conductive carbon ink on a polyester or PVDF substrate. As another example, the pads and traces may be plated copper traces on a flexible polyester or Kapton substrate. As yet another example, the pads and traces may be part of a printed circuit board. - With reference again to
FIGURE 1 and further reference toFIGURE 6 , theelectrical contacts 42 of thepatch connector 26 of this embodiment include a connector printed circuit layer orboard 102, which is bonded to theretention seal layer 62 via a diecut piece of a non-conductive pressure sensitive adhesive layer (PSA) 104. Theretention seal layer 62 and pressure sensitiveadhesive layer 104 includerespective openings conductive epoxy 107 which electrically connects thepatch circuit layer 32 toconductive pads 108 disposed on the printedcircuit board 102. More specifically, during the assembly, the pressure sensitiveadhesive layer 104 is aligned over printedcircuit pads 110 on thepatch circuit layer 32, which for example is, a printed polyester layer, and adhered to theretention seal layer 62. Each of theopenings 106 in thePSA layer 104 is filled with conductive epoxy. The connector printedcircuit board 102 is aligned with thePSA layer 104. Theentire patch assembly 14 is placed in a heated chamber to hasten the cure of the conductive epoxy. Alternatively, since the conductive epoxy is trapped between thecircuit board 102 and thepatch circuit layer 32, the conductive epoxy may be allowed to cure at room temperature as thepatch assembly 14 is packaged and shipped. - In one embodiment, the
top surface 38 of theconnector 26, includes a multipin straight connector or right angle header with or without a housing snap which enables the electromechanical attachment of thepatch assembly 14 to themonitoring device 10. In one embodiment, the sealing gasket is bonded to thetop surface 38 of theconnector 26. Upon insertion of theconnector 26 into themonitoring device 10, the gasket compresses to protect the connector pins from liquid entry. - With continuing reference to
FIGURE 1 and further reference toFIGURE 7 , the patch connectorelectrical connection interface 42 includes a single piece orlayer 112 of Z-axis conductive pressure sensitive adhesive (PSA), which directly electrically connects thepatch electrodes 32 to thedevice contacts 50 on thebottom surface 52 of themonitoring device 10. To establish a reliable connection, the Z-axis conductive PSA is pressed between thetop surface 38 of thepatch assembly 14 and thebottom surface 52 of themonitoring device 10 with a sufficient amount of pressure for a sufficient amount of time, which is specific to the individual material. For example, a pressure of 30 PSI which is applied for 5 seconds may be sufficient for 3M 9703™, but may not be sufficient for a different PSA. Many conductive PSA materials are not suitable for use alone as structural PSA layers. A strengthening, non-conductive PSA layer is applied around such conductive PSA to improve strength and support, and to bring the Z-axis conductive PSA into compression which provides a more consistent electrical connection. - With continuing reference to
FIGURE 1 and further reference toFIGURE 8 ,9A and 9B , thepatch assembly connector 26 of this embodiment includes aclip 114. Theclip 114 includes thetop surface 38 proximate themonitoring device 10,bottom surface 40 proximate thepatch 22 and the connector printedcircuit layer 102, such as a flexible circuit layer, which mates with thepatch circuit layer 32, which, in this embodiment, is a flexible circuit layer disposed between first and seconddielectric layers flexible circuit layer 102 is aligned so that its traces mate with respective traces of thepatch circuit layer 32. To improve electrical connection between the two sets of traces, a low-impedance Z-axis conductive adhesive is applied to the connectorflexible circuit 102 which bonds the connector printedcircuit 102 to thepatch circuit 32 and electrically connects the traces. Theclip 114 includes a non-conductive layer of pressuresensitive adhesive 119 which bonds theclip 114 to thepatch 22 mechanically and structurally. The clipnon-conductive PSA layer 119 provides the liquid-proof seal between theclip 114 and thepatch 22. - With continuing reference to
FIGURES 1 and8 and further reference toFIGURES 10A and10B , a tongue or extendingportion 120 of theclip 114 is inserted into aslot 122 of acase 124 themonitoring device 10. Once inside themonitoring device 10, the traces on the bottom surface of theclip tongue 120 mate with thedevice contacts 50 in themonitoring device 10. This completes the electrical circuit between the patch traces and themonitoring device 10. - With continuing reference to
FIGURES 1 and8 and further reference toFIGURES 11A, 11B and 11C , themonitoring device 10 snaps completely into theclip 114, which is, for example, a snap action clip. As a result of such mechanical connection, thedevice contacts 50, such as pins and leaf springs, on thebottom surface 52 of themonitoring device 10 connect electrically with correspondingpatch metal contacts 42, i.e., gold-plating over nickel-plated copper pins, or the connector printedcircuit board 102 of theclip 114 through a single piece of thin, Z-axisconductive elastomer sheet 126. Theelastomer sheet 126 compresses as theclip 114 snaps onto themonitoring device 10. Once compressed, the conductive particles, i.e. carbon particles or fibers, are pressed against conductive surfaces of the clip and monitoring device making a connection. In addition, since the elastomer sheet is conductive in the Z-axis only, such elastomer sheet forms a seal against outside moisture entry when compressed. Thepatch 22 is attached to theclip 114 with one or more pieces of pressure sensitive adhesive. A conductive adhesive, such as 3M 9703™, can be used to make the electrical connection between the patch traces and the metal contacts in theclip 114. A piece of non-conductive structural adhesive may be used around the conductive PSA layer to improve the strength and reliability of the bond between thepatch 22 andclip 114. - With reference to
FIGURE 12 , to eliminate the conductive adhesive between theclip 114 and thepatch 22, theclip 114 includes one or more extendingportions 120 which are inserted through thepatch circuit layer 32. Theclip 114 is held in place by theframe layer 72. The patch connectorelectrical connection interface 42 includes thelayer 126 of a Z-axis conductive elastomer material which provides electrical connection between themonitoring device 10 and thepatch circuit layer 32. The patch traces are directly exposed to the Z-axisconductive silicone layer 126, which electrically connects the patch traces to thedevice contacts 50 on thebottom surface 52 of themonitoring device 10. Such direct connection is more reliable and robust, since every additional electrical interface increases the risk for the patch failure. By passing under and through thepatch circuit 32 and mechanically by snap action connecting with themonitor 10, theclip 114 provides a rigid support surface against which themonitoring device 10 may press into the patch traces. The rigid surface provides a more consistent pressure between the monitoring device and patch contacts. - With reference to
FIGURE 13 , thedevice contacts 50 of themonitoring device 10 include pins which make direct contact with thepatch circuit layer 32. The monitoring device pins 50 each includes ashoulder 128, which tapers to a point near the end. Thepins 50 press through or makeopenings bottom layers top layer openings 130 have smaller diameter than thebottom layer openings 132. Further, the diameter of each top layer opening 130 is smaller than the dimensional measurements of theshoulder 128 of thepins 50. The top layer opening 130 trapsrespective shoulder 128 of eachpin 50 once the pins are pressed through theopenings pins 50 to contact exposed pads or traces on thepatch circuit layer 32. - With reference again to
FIGURE 1 and further reference toFIGURES 14 and15 , the patch connectorelectrical connection interface 42 includes a single band of higher-impedance Z-axisconductive elastomer 140, such as silicone, surrounded by a single, conductive or non-conductiveelastic seal 142. When compressed, theconductive silicone 140 provides electrical connection between thedevice contacts 50 on thebottom surface 52 of themonitoring device 10 and conductive traces on thepatch 22. For example, theconductive silicone 140 can be inserted or over-molded to pass completely through theclip 114 and make contact with themonitoring device 10 on the cliptop surface 38 and the conductive traces or pads of thepatch 22 on theclip bottom surface 40. E.g., no additional clip contacts are required. Since theconductive silicone 140 electrically connects the patch traces to thedevice contacts 50 on themonitoring device 10, non-conductive PSA may be used to bond the patch layers to theclip 114. Although, thedevice contacts 50 of themonitoring device 10 are shown to be flush with thebottom surface 52 of themonitoring device 10, it is contemplated that thedevice contacts 50 of themonitoring device 10 can extend beyond thebottom surface 52 of themonitoring device 10 or be recessed into thebottom surface 52 of themonitoring device 10. Theclip extensions 120 releasably engage thecase 124 of themedical device 10 to hold themedical device 10 and thepatch 22 together. - To ensure enough compression of the conductive silicone, the patch traces may be backed up with another material, such as a thicker, firmer material, e.g. 0.032 inch-thick polyethylene foam.
- The
elastic seal 142 surrounds the single piece or array of conductive silicone element(s) and, when compressed against the base of the monitoring device, prevents liquid entry into the contact area. - First alignment structures or means 144 disposed on the
first clip surface 38 mate with second alignment structures or means 146 disposed on thebottom surface 52 of themonitoring device 10 so that the connectorelectrical contacts 42 are aligned with thedevice contacts 50. Although pin-type alignment structures are shown, other alignment structures may be employed, such as mated notches and tongues along the periphery of the clip surfaces. Also, themedical device 10 andclip 114 may be asymmetrically shaped such thatdevice 10 insertion can be accomplished in only one orientation intoclip 114. - In one embodiment, individual conductive silicone contacts are overmolded or post-inserted into the
rigid clip 114 in place of a single piece of z-axisconductive elastomer 140. The individual contacts can also be co-molded into a single connector or subassembly part using a non-conductive elastomer or polymer to bridge the gap between each contact. - To improve electrical conductivity between the individual conductive elastic contacts and the patch, the bottom surface of the contacts may be printed or otherwise coated with conductive ink. In addition, a piece of Z-axis conductive adhesive may be laminated between the patch and the clip contacts, inside a window in the surrounding structural pressure sensitive adhesive
- With continuing reference to
FIGURE 1 and further reference toFIGURES 16A and 16B , similar to the embodiments described above, therigid clip 114 mechanically attaches thepatch 22 to themonitoring device 10. The clipelectrical contacts 42 include individual pieces orcontacts 150 of the conductive elastomer, such as conductive silicone, which electrically connect the patch traces to thedevice contacts 50 on thebottom surface 52 of themonitoring device 10. Each individualconductive silicone piece 150 is surrounded by anelastomer seal 152. Such individual seals allow the individual pieces of silicon to maintain isolation from each other even if one seal fails. - In one embodiment, the
elastomer contacts 150 are molded or inserted partway into theclip 114. The clipelectrical contacts 42 further include silver/silver chloride (Ag/AgCl) platedplugs 154 which are insert-molded or post-inserted or applied into thebottom surface 40 of theclip 114 throughopenings 156 to make contact with each respectiveconductive elastomer contact 150 and thefirst hydrogel layer 28 of thepatch 22. - As another example, the
plug 154 is constructed from a conductive metal or plastic, such as a glass-fiber reinforced conductive acrylonitrile butadiene styrene (ABS), that is molded into shape. It is contemplated that the plug may or may not include a flange for touching the gel, and a post for press-fitting into the clip. The formed or molded plug is plated with the Ag/AgCl before or after molding. - As another example, the
plug 154 can be die cut from a thin sheet of metal or conductive polymer, and then plated with the Ag/AgCl. - With continuing reference to
FIGURE 1 and further reference toFIGURES 17A and 17B , theclip 114 is similar to the clip of the embodiments described above, except the Ag/AgCl plugs 154 are omitted. Thepieces 150 of the conductive elastomer material are overmolded through the entire thickness of theclip 114 so that thepieces 150 extend out or are flush with both the top andbottom surfaces clip 114. The exposedbottom surface 40 makes contact with metal traces or contacts of thepatch 22, while thetop surface 38 is exposed for contact with thedevice contacts 50 of themonitoring device 10. - In one embodiment, to create a half-cell reaction, the surface of each
piece 150 of the elastomer material, such as silicone, is pad printed or screen-printed with a Ag/AgCl ink to make contact with the firstconductive hydrogel layer 28 to form a half-cell reaction. To adequately adhere to the surface of the silicone pieces, the ink may be formulated in a silicone base. - In another embodiment, to create a half-cell reaction, the pieces of the conductive silicone are loaded with Ag/AgCl particles. E.g., the Ag/AgCl particles may be the conductive material in the silicone. If the loading is of high concentration, the Ag/AgCl particles in the cured silicone will form an adequate half-cell reaction as at the contact with the hydrogel.
- With continuing reference to
FIGURE 1 and further reference toFIGURES 18A and 18B , theclip 114 includesclip openings 160. The clipelectrical contacts 42 includerings 162 of Ag/AgCl which are pad or screen printed directly to thebottom surface 40 of theclip 114 to surround eachclip opening 160. The clipelectrical contacts 42 further includeconductive silicone 164 which is overmolded completely through theopenings 160 to overlap a portion of the printed Ag/AgCl rings 162 on thebottom surface 40 which contacts thepatch 22. Upon contact with thefirst hydrogel layer 28, therings 162 of Ag/AgCl create the half-cell reaction. Theconductive silicone 164, which overlaps each printedring 162 conducts the body signals to the contacts of themonitoring device 10. - In one embodiment, a vacuum is used to draw the Ag/AgCl ink inside the
clip openings 160. In this design, the conductive silicone does not need to flow all the way through theclip opening 160 since the contact with the Ag/AgCl is made inside theclip opening 160. - With continuing reference to
FIGURE 1 and further reference toFIGURE 19 , thedevice contacts 50 include reusable conductive posts which are molded or inserted into the bottom housing of themonitoring device 10 to make direct contact with thehydrogel layer 28 of thepatch assembly 14. For example, such posts are formed of metal or molded of conductive polymer. After forming, the posts are plated with Ag/AgCl before being inserted into the housing of themonitoring device 10. Since the posts can be cleaned between each application of thepatch 22 to the patient, the Ag/AgCl coating should be thick and robust enough to withstand multiple cleanings and patch applications. Alternatively, the posts may be sintered out of Ag/AgCl. This eliminates plating the posts afterwards, and ensures that Ag/AgCl is not taken off the posts. Thepatch 22 may be mechanically attached to themonitoring device 10 in several ways. - With continuing reference to
FIGURES 1 and19 and further reference toFIGURE 20 , thepatch 22 is attached to themonitoring device 10 with theclip 114, which is bonded to thepatch 22 with anon-conductive PSA layer 165. Through the matchingopenings clip 114 and the patch layers 24, the posts ordevice contacts 50 pass through the patch layers 24 and touch thefirst hydrogel layer 28 directly. Individual protective O-rings 168 are provided to seal and protect each post from liquid entry during bathing or showering. - As another example, the
patch 22 can be attached to themonitoring device 10 via a non-conductive PSA layer, or a multi-layer PSA laminate. Openings are provided in the PSA layer to allow the Ag/AgCl posts to pass through and contact thefirst hydrogel layer 28. The PSA layer holds thepatch 22 to themonitoring device 10 and seals around and between the individual posts. To ensure a consistent seal, a thicker PSA layer, or a thin (20 mil or 32-mil) PE or PU foam with adhesive on both sides may be used in place of the thick PSA. Being compressible, the foam compensates well for variations of Ag/AgCl post protrusion distances. In one embodiment, different adhesives on each side of the foam or PSA layer are used. More specifically, an aggressive PSA layer is used on the patch side and a less aggressive, easier to peal PSA layer, is used on the monitoring device side for the PSA material to come cleanly off of the monitoring device so that themonitoring device 10 can quickly be cleaned and prepared for use with a new patch. - The direct connection of the silver/silver chloride contacts with the
hydrogel layer 28 eliminates conductive traces on thepatch 22 and minimizes the number of connections required to make connection between the monitoring device and the base layer, improving reliability and potentially decreasing noise artifact. Without traces, thepatch circuit layer 32 can become relatively inexpensive to manufacture. This also increases the material choices available for the circuit layer. For example, thinner polyester or PVDF films may be used if no printing is required. As the thinner films are used, thepatch 22 becomes increasingly flexible and comfortable. - As mentioned above, Ag/AgCl is desirable as the hydrogel contact material for monitoring electrodes due to the stability of the resulting half-cell reaction.
- With continuing reference to
FIGURE 1 and further reference toFIGURE 21 , theclip 114 is molded over a part of thepatch circuit layer 32 via a technique similar to in-mold decorating techniques. More specifically, in-mold decorating techniques place a pre-formed printed polyester film into the injection mold against the inside surface of the mold. The molten polymer is then shot against the film and cooled. Once cooled, the polyester film is inseparable from the polymer. In one embodiment, thepatch circuit layer 32 is a thin, printed polyester layer, suitable for placement in an injection-molding tool. As one example, thepatch circuit 32 may be preformed into a shape. As another example, thepatch circuit 32 may nor be preformed into a shape. After insertion in the tool, the clip material is injected and cooled against its surface. This creates a strong mechanical bond between thepatch circuit 32 andclip 114. Theclip 114 includes the openings (not shown), which are positioned to communicate with the contact pads (not shown) in thecircuit layer 32. The clipelectrical connection interface 42 includes conductive silicone which is subsequently overmolded into the clip openings to form a robust electrical connection with thepatch circuit 32. Non-conductive elastomeric rings may be molded or bonded around each conductive silicone contact for sealing against the surface of themonitoring device 10. - With continuing reference to
FIGURE 21 and further reference toFIGURES 22, 23, 24 and 25 , theclip 114 and circuit sub-assembly is bonded to thepatch 22. The foam layer orsupport layer 72 is coated on both sides with non-conductive PSA material. The PSA material connects and seals thepatch circuit layer 32 andclip 114 to thefoam layer 72. Thefoam layer 72 is attached to thehydrogel pieces 28 andretention seal 62. -
FIGURE 22 shows thepatch circuit 32 proximate to the patch layers 24, with a patch side printedcircuit 170. -
FIGURE 23 shows thepatch circuit 32 proximate to theclip 114 with clip side printedcontact pads 172. -
FIGURE 24 shows theclip 114 and thepatch 22. Theclip 114 includesclip openings 166 for the monitoring device posts or overmolding of conductive silicone contacts. - In one embodiment, the
monitoring device 10 includessensors 180 which detect body motion such as respirations, footfalls, heart beats and CPR compressions. - In this manner, by connecting the monitoring device to the medical patch via the thin clip helps to detect motion artifact in the monitored signal, which allows the signal processor in the monitoring device to compensate accordingly.
- With reference again to
FIGURE 1 , in one embodiment, thepatch connector 26 is a low-profile electro-mechanical connection that creates a rigid patch area only in the center of the patch, leaving the outer areas of the patch flexible to bend and stretch with the skin. This minimizes the affect of monitor movement on the patch, thus reducing noise artifact due to monitor movement. - Other embodiments exist which include combinations of embodiments mentioned herein, combinations of low and higher-impedance contact mechanisms on the same connector, and embodiments that many include one, multiple or no seals.
- The invention described above can be applied to other fields where electronic devices are attached to be held firmly to the skin to monitor physiologic signals or responses such as cardiac stress testing. One example is the athletic training field where electronic devices are worn to monitor performance. Other examples include child monitoring, such as for SIDS where a monitor is attached to the child for long periods of time to monitor cardiac and respiration activity, biosignal monitoring to monitor the health of the animals, and transdermal drug delivery systems which monitor certain patient parameters to determine when additional drug is required, how much is required, and the effects of drug dosage.
- The methods and apparatuses described above provide a low-profile method of mechanically attaching the monitoring device to a thin, flexible patch. The thin, low-profile connections allow the monitoring device to become closely coupled to the bio-electrode patch enabling motion artifact detection by the monitoring device. When the electro-mechanical connection is thin enough, motion sensors in the monitoring device (accelerometers or piezo-electric sensors) can be designed to detect patient movements including footfalls, respirations and heartbeats.
- The methods and apparatuses described above prevent the monitoring device from directly contacting the skin.
- The methods and apparatuses described above include a low-profile, wire-free method of electrically connecting the patch electrodes to the monitoring device. Eliminating the wires can reduce electrical artifact in the bioelectric signal.
- The methods and apparatuses described above include a method for creating a liquid-proof seal around each patch contact, or around the group of contacts, when the patch is connected to the monitoring device. Sealing between electrodes ensures that shorting does not occur during a shower or spill. The methods and apparatuses described can also be implemented without the seals.
- The methods and apparatuses described above include a rigid central portion. Since the monitoring/therapy device is a relatively large mass attached to the skin, small movements or rotations in the device can create large disturbances in the monitored signal. A rigid portion in the center of the connector stabilizes the monitoring/therapy device and helps reduce motion artifact by preventing excess movement and rotation of the device during patient movement. When only the center is rigid, this connection scheme allows the edges of the patch to conform to body contours.
- The methods and apparatuses described above are user friendly in that they may allow single step connections (both the mechanical and electrical connections are accomplished at the same time with the same user action). They can be performed with a single hand, and they do not require or transmit heavy forces to the body. They also allow attaching the monitoring device to the patch before attaching the patch to the skin.
- The methods and apparatuses described above take advantage of the high-impedance patient monitoring electronics in the monitoring device. When impedances of the monitoring electronics are very high (i.e. Giga-ohm range), connector embodiments can be developed which are in the 1000 - 10,000 Ohm range without significantly affecting the monitored signal. The impedance attribute of the connector can be either high - 100 - 10,000 Ohm, medium 20-200 Ohm, or low, < 20 Ohm.
- The invention has been described with reference to the preferred embodiments. Obviously, modifications and alterations will occur to others upon reading and understanding the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.
Claims (12)
- A modular device (8) for attachment to the skin (18) of a patient (12) comprising:a medical device (10) which includes device electrical contacts (50) on a bottom surface (52) of the medical device (1);a patch laminate (22) including a plurality of layers (24), the plurality of layers (24) comprising a conductive first layer (28) for establishing a direct contact with the skin (18);a patch connector (26), which includes connector electrical contacts (42) in electrical communication with the first conductive layer (28) and establishes an electrical communication path between the skin (18) and medical device contacts (50) and which affixes the medical device (10) in close proximity to the patch laminate (22),wherein the plurality of layers (24) further comprises an electrical distribution layer (32) which is electrically connected with the connector electrical contacts (42) and with each of a plurality of first electrodes defined in the first conductive layer (28), andwherein the patch connector includes a generally rigid clip (114) including a clip first surface (38), and a clip second surface (40), the clip first surface (38) including extending portions (120) which releasably engage a case (124) of the medical device (10) to hold the connector contacts (42) and the device contacts (50) in electrical communication; the patch connector (26) further:providing a rigid patch area in a center of the patch laminate (22), and a flexible outer area of the patch laminate (22), andcomprising a layer of a Z-axis conductive elastomer material (126) configured to be compressed as the clip (114) is snapped onto the medical device (10) and to provide an electrical connection between the medical device contacts (50) and the connector electrical contacts (42).
- The device as set forth in claim 1, wherein the patch connector (26) further includes:alignment means (144, 146) for indexing the connector electrical contacts (42) to match the medical device contacts (50).
- The device as set forth in claim 1, further including:a fluid seal (142, 152) which surrounds the connector contacts (42).
- The device as set forth in claim 1, wherein the connector electrical contacts (42) include at least one of:pins (80);snaps (48);silver/silver chloride elements (154, 162); andelectrically conductive elastic segments (150, 164).
- The device as set forth in claim 1, wherein the connector electrical contacts (42) include:a band (140) of a z-axis conductive elastic material in contact with the electrical distribution layer (32).
- The device as set forth in claim 1, further comprising:a sensor (180) which detects at least one parameter attributable to a motion of the skin.
- The device as set forth in claim 1, wherein the clip (114) passes under the electrical distribution layer (32) and the extending portions (120) thereof are inserted through the electrical distribution layer (32) for providing a rigid support surface.
- A method of connecting a medical device (10) to a subject base surface (18) comprising:disposing a patch laminate (22) which includes a conductive first layer (28) in direct electrical communication with the base surface;electromechanically connecting the patch to a medical device connection interface (36) which includes a first connector (46) and device contacts (50) via a patch connector (26) wherein the patch connector includes connector electrical contacts (42) in electrical communication with the first conductive layer (28), and a generally rigid clip (114) including a clip first surface (38), and a clip second surface (40), the clip first surface (38) including extending portions (120), wherein a rigid patch area is provided in a center of the patch laminate (22), the patch laminate (22) comprising a flexible outer area,electrically connecting an electrical distribution layer (32) of the patch laminate (22) with the connector electrical contacts (42) and with each of a plurality of first electrodes defined in the first conductive layer (28),the step of connecting the patch including:releasably engaging a case (124) of the medical device (10) with the extending portions (120) of the clip first surface (38) to hold the connector contacts (42) and the device contacts (50) in electrical communication, thereby establishing an electrical communication path between the subject base surface (18) and the medical device contacts (50) and affixing the medical device (10) in close proximity to the patch laminate (22),wherein a layer of a Z-axis conductive elastomer material (126) is compressed as the clip (114) is snapped onto the medical device (10) and provides an electrical connection between the medical device contacts (50) and the connector electrical contacts (42).
- The method as set forth in claim 8, wherein the patch layers further include second electrodes (32) and further including:disposing the first electrodes in direct electrical communication with the base surface and the second electrodes;disposing the second electrodes in electrical communication with the device contacts; andtransmitting electrical signals generated in the base surface to the medical device contacts.
- The method as set forth in claim 9, further including:sealing the electrical communication path from the base surface to the device contacts against fluids with a sealing layer.
- The method of claim 10, wherein the patch connector includes electrical contacts and the sealing layer includes elastic rings which each surrounds each respective individual patch electrical contact.
- The method as set forth in claim 8, wherein said connecting step occurs after said disposing step.
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PCT/IB2006/054019 WO2007063436A1 (en) | 2005-11-30 | 2006-10-30 | Electro-mechanical connector for thin medical monitoring patch |
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EP1956973B1 true EP1956973B1 (en) | 2017-09-13 |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2024015381A1 (en) * | 2022-07-11 | 2024-01-18 | Abbott Diabetes Care Inc. | Systems, devices, and methods for analyte monitoring |
Families Citing this family (204)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1706178B1 (en) | 2004-01-22 | 2013-04-24 | Rehabtronics Inc. | System for routing electrical current to bodily tissues via implanted passive conductors |
US7545272B2 (en) | 2005-02-08 | 2009-06-09 | Therasense, Inc. | RF tag on test strips, test strip vials and boxes |
US9198608B2 (en) | 2005-04-28 | 2015-12-01 | Proteus Digital Health, Inc. | Communication system incorporated in a container |
EP3827747A1 (en) | 2005-04-28 | 2021-06-02 | Otsuka Pharmaceutical Co., Ltd. | Pharma-informatics system |
US8730031B2 (en) | 2005-04-28 | 2014-05-20 | Proteus Digital Health, Inc. | Communication system using an implantable device |
JP5714210B2 (en) | 2005-09-01 | 2015-05-07 | プロテウス デジタル ヘルス, インコーポレイテッド | Implantable wireless communication system |
JP2009544338A (en) | 2006-05-02 | 2009-12-17 | プロテウス バイオメディカル インコーポレイテッド | Treatment regimen customized to the patient |
US7761131B2 (en) * | 2006-05-30 | 2010-07-20 | Tyco Healthcare Group Lp | Medical electrode containing a hydrophilic polymer |
EP2083680B1 (en) | 2006-10-25 | 2016-08-10 | Proteus Digital Health, Inc. | Controlled activation ingestible identifier |
EP2069004A4 (en) | 2006-11-20 | 2014-07-09 | Proteus Digital Health Inc | Active signal processing personal health signal receivers |
ES2930588T3 (en) | 2007-02-01 | 2022-12-19 | Otsuka Pharma Co Ltd | Ingestible Event Marker Systems |
KR101528748B1 (en) | 2007-02-14 | 2015-06-15 | 프로테우스 디지털 헬스, 인코포레이티드 | In-body power source having high surface area electrode |
EP2124725A1 (en) | 2007-03-09 | 2009-12-02 | Proteus Biomedical, Inc. | In-body device having a multi-directional transmitter |
US8115618B2 (en) | 2007-05-24 | 2012-02-14 | Proteus Biomedical, Inc. | RFID antenna for in-body device |
JP5451606B2 (en) * | 2007-07-06 | 2014-03-26 | コーニンクレッカ フィリップス エヌ ヴェ | Shielded biomedical electrode patch |
US9757554B2 (en) | 2007-08-23 | 2017-09-12 | Bioness Inc. | System for transmitting electrical current to a bodily tissue |
US8738137B2 (en) * | 2007-08-23 | 2014-05-27 | Bioness Inc. | System for transmitting electrical current to a bodily tissue |
JP5425077B2 (en) * | 2007-08-23 | 2014-02-26 | バイオネス インコーポレイテッド | System for transmitting current to body tissue |
FI2192946T3 (en) | 2007-09-25 | 2022-11-30 | In-body device with virtual dipole signal amplification | |
KR101586193B1 (en) | 2007-11-27 | 2016-01-18 | 프로테우스 디지털 헬스, 인코포레이티드 | Transbody communication systems employing communication channels |
AU2009221781B2 (en) | 2008-03-05 | 2014-12-11 | Otsuka Pharmaceutical Co., Ltd. | Multi-mode communication ingestible event markers and systems, and methods of using the same |
BRPI0906154B8 (en) | 2008-03-10 | 2021-06-22 | Koninklijke Philips Eletronics N V | ecg monitoring system for cardiac monitoring of an outpatient |
CN101984743B (en) | 2008-03-10 | 2013-06-19 | 皇家飞利浦电子股份有限公司 | Continuous outpatient ECG monitoring system |
US9737225B2 (en) | 2008-06-24 | 2017-08-22 | Biosense Webster, Inc. | Patch and sensor assembly for use in medical device localization and mapping systems |
US9014778B2 (en) * | 2008-06-24 | 2015-04-21 | Biosense Webster, Inc. | Disposable patch and reusable sensor assembly for use in medical device localization and mapping systems |
MY154234A (en) | 2008-07-08 | 2015-05-15 | Proteus Digital Health Inc | Ingestible event marker data framework |
US8419982B2 (en) | 2008-09-11 | 2013-04-16 | Covidien Lp | Conductive compositions and method |
US8055334B2 (en) | 2008-12-11 | 2011-11-08 | Proteus Biomedical, Inc. | Evaluation of gastrointestinal function using portable electroviscerography systems and methods of using the same |
US9659423B2 (en) | 2008-12-15 | 2017-05-23 | Proteus Digital Health, Inc. | Personal authentication apparatus system and method |
WO2013012869A1 (en) | 2011-07-21 | 2013-01-24 | Proteus Digital Health, Inc. | Mobile communication device, system, and method |
US9439566B2 (en) | 2008-12-15 | 2016-09-13 | Proteus Digital Health, Inc. | Re-wearable wireless device |
WO2010077851A2 (en) | 2008-12-15 | 2010-07-08 | Corventis, Inc. | Patient monitoring systems and methods |
TWI424832B (en) | 2008-12-15 | 2014-02-01 | Proteus Digital Health Inc | Body-associated receiver and method |
JP2012514799A (en) | 2009-01-06 | 2012-06-28 | プロテウス バイオメディカル インコーポレイテッド | Methods and systems for ingestion related biofeedback and individual pharmacotherapy |
WO2011001314A1 (en) * | 2009-07-01 | 2011-01-06 | Koninklijke Philips Electronics, N.V. | Low cost-low profile lead set connector |
WO2011033632A1 (en) * | 2009-09-16 | 2011-03-24 | Kanazawa Kyohei | Waterproof connector, waterproof connection adapter, and waterproof connection structure |
TWI517050B (en) | 2009-11-04 | 2016-01-11 | 普羅托斯數位健康公司 | System for supply chain management |
US9451897B2 (en) * | 2009-12-14 | 2016-09-27 | Medtronic Monitoring, Inc. | Body adherent patch with electronics for physiologic monitoring |
EP2515745B1 (en) | 2009-12-23 | 2016-07-20 | DELTA, Dansk Elektronik, Lys & Akustik | Monitoring device for attachment to the skin surface |
US8560040B2 (en) | 2010-01-04 | 2013-10-15 | Koninklijke Philips N.V. | Shielded biomedical electrode patch |
SG182825A1 (en) | 2010-02-01 | 2012-09-27 | Proteus Biomedical Inc | Data gathering system |
US8355770B2 (en) * | 2010-03-22 | 2013-01-15 | Idt Technology Limited | Conductive silicone material for human skin electrode |
KR101513288B1 (en) * | 2010-05-12 | 2015-04-17 | 아이리듬 테크놀로지스, 아이엔씨 | Device features and design elements for long-term adhesion |
TWI557672B (en) | 2010-05-19 | 2016-11-11 | 波提亞斯數位康健公司 | Computer system and computer-implemented method to track medication from manufacturer to a patient, apparatus and method for confirming delivery of medication to a patient, patient interface device |
US8548557B2 (en) | 2010-08-12 | 2013-10-01 | Covidien Lp | Medical electrodes |
ES2720127T3 (en) | 2010-09-16 | 2019-07-18 | Neurometrix Inc | Automated speed and amplitude conduction measuring instrument of the sural nerve |
US10004445B2 (en) | 2010-09-16 | 2018-06-26 | Neurometrix, Inc. | Apparatus and method for stimulator on-skin short detection |
US9037477B2 (en) | 2010-10-08 | 2015-05-19 | Cardiac Science Corporation | Computer-implemented system and method for evaluating ambulatory electrocardiographic monitoring of cardiac rhythm disorders |
US8239012B2 (en) | 2010-10-08 | 2012-08-07 | Cardiac Science Corporation | Microcontrolled electrocardiographic monitoring circuit with differential voltage encoding |
US20120089000A1 (en) | 2010-10-08 | 2012-04-12 | Jon Mikalson Bishay | Ambulatory Electrocardiographic Monitor For Providing Ease Of Use In Women And Method Of Use |
US8613708B2 (en) | 2010-10-08 | 2013-12-24 | Cardiac Science Corporation | Ambulatory electrocardiographic monitor with jumpered sensing electrode |
US9775561B2 (en) * | 2010-12-23 | 2017-10-03 | Covidien Lp | System method and device for monitoring physiological parameters of a person |
US9375179B2 (en) * | 2010-12-23 | 2016-06-28 | Biosense Webster, Inc. | Single radio-transparent connector for multi-functional reference patch |
US9439599B2 (en) | 2011-03-11 | 2016-09-13 | Proteus Digital Health, Inc. | Wearable personal body associated device with various physical configurations |
US9756874B2 (en) | 2011-07-11 | 2017-09-12 | Proteus Digital Health, Inc. | Masticable ingestible product and communication system therefor |
WO2015112603A1 (en) | 2014-01-21 | 2015-07-30 | Proteus Digital Health, Inc. | Masticable ingestible product and communication system therefor |
US9128521B2 (en) | 2011-07-13 | 2015-09-08 | Lumo Bodytech, Inc. | System and method of biomechanical posture detection and feedback including sensor normalization |
US8928484B2 (en) | 2011-07-13 | 2015-01-06 | Lumo Bodytech, Inc. | System and method of biomechanical posture detection and feedback |
KR101941171B1 (en) * | 2011-09-26 | 2019-01-23 | 삼성전자주식회사 | Apparatus and method for measuring biological signal |
CN103006199B (en) | 2011-09-26 | 2016-09-28 | 三星电子株式会社 | For measuring equipment and the method for bio signal |
US9235683B2 (en) | 2011-11-09 | 2016-01-12 | Proteus Digital Health, Inc. | Apparatus, system, and method for managing adherence to a regimen |
DE102012105306A1 (en) * | 2012-06-19 | 2013-12-19 | Capical Gmbh | ECG handset |
US9907967B2 (en) | 2012-07-26 | 2018-03-06 | Adi Mashiach | Transcutaneous power conveyance device |
US9511238B2 (en) * | 2012-07-26 | 2016-12-06 | Nyxoah SA | Implant holder and suture guide |
US10244949B2 (en) | 2012-10-07 | 2019-04-02 | Rhythm Diagnostic Systems, Inc. | Health monitoring systems and methods |
US10413251B2 (en) | 2012-10-07 | 2019-09-17 | Rhythm Diagnostic Systems, Inc. | Wearable cardiac monitor |
US10610159B2 (en) | 2012-10-07 | 2020-04-07 | Rhythm Diagnostic Systems, Inc. | Health monitoring systems and methods |
USD850626S1 (en) | 2013-03-15 | 2019-06-04 | Rhythm Diagnostic Systems, Inc. | Health monitoring apparatuses |
AU2013328589A1 (en) * | 2012-10-12 | 2015-05-21 | Delta, Dansk Elektronik, Lys Og Akustik | A monitoring device |
KR101998066B1 (en) * | 2012-11-23 | 2019-10-01 | 삼성전자주식회사 | Signal processing device without mechanical switch for on/off operation |
US11944441B2 (en) * | 2012-12-31 | 2024-04-02 | Suunto Oy | Electro-mechanic assembly and integrated snap connectors |
JP6198849B2 (en) * | 2013-01-24 | 2017-09-20 | アイリズム・テクノロジーズ・インコーポレイテッドiRhythm Technologies,Inc. | Electronic device for monitoring physiological signals and method for removing and replacing parts of the electronic device |
US11744481B2 (en) | 2013-03-15 | 2023-09-05 | Otsuka Pharmaceutical Co., Ltd. | System, apparatus and methods for data collection and assessing outcomes |
WO2014151929A1 (en) | 2013-03-15 | 2014-09-25 | Proteus Digital Health, Inc. | Personal authentication apparatus system and method |
WO2014151925A1 (en) * | 2013-03-15 | 2014-09-25 | Proteus Digital Health, Inc. | Re-wearable wireless device |
WO2014168841A1 (en) | 2013-04-08 | 2014-10-16 | Irhythm Technologies, Inc | Skin abrader |
JP6606067B2 (en) | 2013-06-06 | 2019-11-13 | トライコード ホールディングス,エル.エル.シー. | Modular physiological monitoring system, kit, and method |
EP3586728A1 (en) * | 2013-07-01 | 2020-01-01 | Mayo Foundation for Medical Education and Research | Algorithms for personalization of monitoring signals in remote patient monitoring systems |
EP3047618B1 (en) | 2013-09-20 | 2023-11-08 | Otsuka Pharmaceutical Co., Ltd. | Methods, devices and systems for receiving and decoding a signal in the presence of noise using slices and warping |
JP2016537924A (en) | 2013-09-24 | 2016-12-01 | プロテウス デジタル ヘルス, インコーポレイテッド | Method and apparatus for use with electromagnetic signals received at frequencies that are not accurately known in advance |
US10624551B2 (en) | 2013-09-25 | 2020-04-21 | Bardy Diagnostics, Inc. | Insertable cardiac monitor for use in performing long term electrocardiographic monitoring |
US9433367B2 (en) | 2013-09-25 | 2016-09-06 | Bardy Diagnostics, Inc. | Remote interfacing of extended wear electrocardiography and physiological sensor monitor |
US9775536B2 (en) | 2013-09-25 | 2017-10-03 | Bardy Diagnostics, Inc. | Method for constructing a stress-pliant physiological electrode assembly |
US10251576B2 (en) | 2013-09-25 | 2019-04-09 | Bardy Diagnostics, Inc. | System and method for ECG data classification for use in facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer |
US9619660B1 (en) | 2013-09-25 | 2017-04-11 | Bardy Diagnostics, Inc. | Computer-implemented system for secure physiological data collection and processing |
US9717433B2 (en) * | 2013-09-25 | 2017-08-01 | Bardy Diagnostics, Inc. | Ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation |
US10433748B2 (en) | 2013-09-25 | 2019-10-08 | Bardy Diagnostics, Inc. | Extended wear electrocardiography and physiological sensor monitor |
US9433380B1 (en) | 2013-09-25 | 2016-09-06 | Bardy Diagnostics, Inc. | Extended wear electrocardiography patch |
WO2015048194A1 (en) | 2013-09-25 | 2015-04-02 | Bardy Diagnostics, Inc. | Self-contained personal air flow sensing monitor |
US9504423B1 (en) | 2015-10-05 | 2016-11-29 | Bardy Diagnostics, Inc. | Method for addressing medical conditions through a wearable health monitor with the aid of a digital computer |
US9655538B2 (en) * | 2013-09-25 | 2017-05-23 | Bardy Diagnostics, Inc. | Self-authenticating electrocardiography monitoring circuit |
US9737224B2 (en) | 2013-09-25 | 2017-08-22 | Bardy Diagnostics, Inc. | Event alerting through actigraphy embedded within electrocardiographic data |
US10165946B2 (en) | 2013-09-25 | 2019-01-01 | Bardy Diagnostics, Inc. | Computer-implemented system and method for providing a personal mobile device-triggered medical intervention |
US10736529B2 (en) | 2013-09-25 | 2020-08-11 | Bardy Diagnostics, Inc. | Subcutaneous insertable electrocardiography monitor |
US9700227B2 (en) | 2013-09-25 | 2017-07-11 | Bardy Diagnostics, Inc. | Ambulatory electrocardiography monitoring patch optimized for capturing low amplitude cardiac action potential propagation |
US10806360B2 (en) | 2013-09-25 | 2020-10-20 | Bardy Diagnostics, Inc. | Extended wear ambulatory electrocardiography and physiological sensor monitor |
US9615763B2 (en) | 2013-09-25 | 2017-04-11 | Bardy Diagnostics, Inc. | Ambulatory electrocardiography monitor recorder optimized for capturing low amplitude cardiac action potential propagation |
US10463269B2 (en) | 2013-09-25 | 2019-11-05 | Bardy Diagnostics, Inc. | System and method for machine-learning-based atrial fibrillation detection |
US11723575B2 (en) | 2013-09-25 | 2023-08-15 | Bardy Diagnostics, Inc. | Electrocardiography patch |
US10667711B1 (en) | 2013-09-25 | 2020-06-02 | Bardy Diagnostics, Inc. | Contact-activated extended wear electrocardiography and physiological sensor monitor recorder |
US20190167139A1 (en) | 2017-12-05 | 2019-06-06 | Gust H. Bardy | Subcutaneous P-Wave Centric Insertable Cardiac Monitor For Long Term Electrocardiographic Monitoring |
US10433751B2 (en) | 2013-09-25 | 2019-10-08 | Bardy Diagnostics, Inc. | System and method for facilitating a cardiac rhythm disorder diagnosis based on subcutaneous cardiac monitoring data |
US10799137B2 (en) | 2013-09-25 | 2020-10-13 | Bardy Diagnostics, Inc. | System and method for facilitating a cardiac rhythm disorder diagnosis with the aid of a digital computer |
US10820801B2 (en) | 2013-09-25 | 2020-11-03 | Bardy Diagnostics, Inc. | Electrocardiography monitor configured for self-optimizing ECG data compression |
US9655537B2 (en) | 2013-09-25 | 2017-05-23 | Bardy Diagnostics, Inc. | Wearable electrocardiography and physiology monitoring ensemble |
US9408551B2 (en) | 2013-11-14 | 2016-08-09 | Bardy Diagnostics, Inc. | System and method for facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer |
US10736531B2 (en) | 2013-09-25 | 2020-08-11 | Bardy Diagnostics, Inc. | Subcutaneous insertable cardiac monitor optimized for long term, low amplitude electrocardiographic data collection |
US9408545B2 (en) | 2013-09-25 | 2016-08-09 | Bardy Diagnostics, Inc. | Method for efficiently encoding and compressing ECG data optimized for use in an ambulatory ECG monitor |
US11213237B2 (en) * | 2013-09-25 | 2022-01-04 | Bardy Diagnostics, Inc. | System and method for secure cloud-based physiological data processing and delivery |
US9345414B1 (en) | 2013-09-25 | 2016-05-24 | Bardy Diagnostics, Inc. | Method for providing dynamic gain over electrocardiographic data with the aid of a digital computer |
US9364155B2 (en) | 2013-09-25 | 2016-06-14 | Bardy Diagnostics, Inc. | Self-contained personal air flow sensing monitor |
US9730593B2 (en) | 2013-09-25 | 2017-08-15 | Bardy Diagnostics, Inc. | Extended wear ambulatory electrocardiography and physiological sensor monitor |
US10888239B2 (en) | 2013-09-25 | 2021-01-12 | Bardy Diagnostics, Inc. | Remote interfacing electrocardiography patch |
US9717432B2 (en) | 2013-09-25 | 2017-08-01 | Bardy Diagnostics, Inc. | Extended wear electrocardiography patch using interlaced wire electrodes |
US9795299B2 (en) * | 2013-09-27 | 2017-10-24 | Covidien Lp | Modular physiological sensing patch |
US20150094556A1 (en) * | 2013-09-30 | 2015-04-02 | Yacov GEVA | Detachable electrocardiograpey device |
GB2536163B (en) * | 2013-10-17 | 2017-11-15 | Monica Healthcare Ltd | Apparatus and method for detecting an abdominal electrophysiological signal |
US10084880B2 (en) | 2013-11-04 | 2018-09-25 | Proteus Digital Health, Inc. | Social media networking based on physiologic information |
USD801528S1 (en) | 2013-11-07 | 2017-10-31 | Bardy Diagnostics, Inc. | Electrocardiography monitor |
USD744659S1 (en) | 2013-11-07 | 2015-12-01 | Bardy Diagnostics, Inc. | Extended wear electrode patch |
USD717955S1 (en) | 2013-11-07 | 2014-11-18 | Bardy Diagnostics, Inc. | Electrocardiography monitor |
USD831833S1 (en) | 2013-11-07 | 2018-10-23 | Bardy Diagnostics, Inc. | Extended wear electrode patch |
USD892340S1 (en) | 2013-11-07 | 2020-08-04 | Bardy Diagnostics, Inc. | Extended wear electrode patch |
USD793566S1 (en) | 2015-09-10 | 2017-08-01 | Bardy Diagnostics, Inc. | Extended wear electrode patch |
US10321832B2 (en) * | 2013-11-23 | 2019-06-18 | MAD Apparel, Inc. | System and method for monitoring biometric signals |
US11219396B2 (en) * | 2013-11-23 | 2022-01-11 | MAD Apparel, Inc. | System and method for monitoring biometric signals |
US10292652B2 (en) * | 2013-11-23 | 2019-05-21 | MAD Apparel, Inc. | System and method for monitoring biometric signals |
US11141599B2 (en) | 2014-04-04 | 2021-10-12 | Los Angeles Biomedical Research Institute At Harbor-Ucla Medical Center | Systems, apparatus, and methods for documenting code blue scenarios |
US9743882B2 (en) * | 2014-04-04 | 2017-08-29 | Los Angeles Biomedical Research Institute At Harbor-Ucla Medical Center | Systems, apparatus, and methods for documenting code blue scenarios |
CN103976729A (en) * | 2014-05-22 | 2014-08-13 | 侯月梅 | Long-term dog electrocardiosignal recording device |
WO2015195209A1 (en) * | 2014-06-17 | 2015-12-23 | MAD Apparel, Inc. | System and method for monitoring biometric signals |
US10398376B2 (en) | 2014-06-17 | 2019-09-03 | MAD Apparel, Inc. | Garment integrated electrical interface system and method of manufacture |
KR102391913B1 (en) * | 2014-08-18 | 2022-04-28 | 삼성전자주식회사 | Biometric information measurement device |
EP2995244A3 (en) * | 2014-08-18 | 2016-07-06 | Samsung Electronics Co., Ltd. | Wearable biometric information measurement device |
KR101507493B1 (en) * | 2014-10-22 | 2015-03-30 | (주)와이브레인 | Electrical stimulating device |
US20160120434A1 (en) | 2014-10-31 | 2016-05-05 | Irhythm Technologies, Inc. | Wireless physiological monitoring device and systems |
USD753832S1 (en) * | 2014-11-11 | 2016-04-12 | Kinpo Electronics, Inc. | Apparatus for measuring physiological signal |
TWI547264B (en) * | 2015-01-12 | 2016-09-01 | 李順裕 | Measurement patch device |
EP3236842A4 (en) | 2015-02-09 | 2017-11-29 | Vios Medical Singapore Pte Ltd | Patient worn sensor assembly |
US10398335B2 (en) * | 2015-08-05 | 2019-09-03 | Preventice Technologies, Inc. | Bridge connectors employing flexible planar bodies having signal pathways coupling control devices with biometric sensors |
US10448844B2 (en) | 2015-08-31 | 2019-10-22 | Masimo Corporation | Systems and methods for patient fall detection |
JP6717087B2 (en) | 2015-09-04 | 2020-07-01 | オムロンヘルスケア株式会社 | Low frequency treatment device, main body for low frequency treatment device, pad for low frequency treatment device, combination of pad and holder for low frequency treatment device |
JP6646887B2 (en) | 2015-09-04 | 2020-02-14 | オムロンヘルスケア株式会社 | Low frequency therapy device and pad for low frequency therapy device, main body for low frequency therapy device, holder for low frequency therapy device, combination of pad and holder for low frequency therapy device |
USD766447S1 (en) | 2015-09-10 | 2016-09-13 | Bardy Diagnostics, Inc. | Extended wear electrode patch |
JP6768673B2 (en) * | 2015-09-11 | 2020-10-14 | フクダ電子株式会社 | Biological information measuring device |
US20200229706A1 (en) * | 2015-09-11 | 2020-07-23 | Fukuda Denshi Co., Ltd. | Biological information measurement device |
US10314520B2 (en) | 2015-10-02 | 2019-06-11 | Seismic Holdings, Inc. | System and method for characterizing biomechanical activity |
WO2017059368A1 (en) * | 2015-10-02 | 2017-04-06 | Lumo BodyTech, Inc | System and method for run tracking with a wearable activity monitor |
KR102547818B1 (en) | 2015-12-15 | 2023-06-26 | 삼성전자주식회사 | Connector assembly |
US10463909B2 (en) | 2015-12-27 | 2019-11-05 | Seismic Holdings, Inc. | System and method for using performance signatures |
US10959647B2 (en) | 2015-12-30 | 2021-03-30 | Seismic Holdings, Inc. | System and method for sensing and responding to fatigue during a physical activity |
CN105662337B (en) * | 2015-12-30 | 2018-08-17 | 博迪加科技(北京)有限公司 | A kind of signal processing apparatus and intelligent clothing |
US10993635B1 (en) | 2016-03-22 | 2021-05-04 | Flextronics Ap, Llc | Integrating biosensor to compression shirt textile and interconnect method |
WO2018013447A1 (en) * | 2016-07-14 | 2018-01-18 | Lifelens Technologies, Llc | Thin film support structures |
KR102051875B1 (en) | 2016-07-22 | 2019-12-04 | 프로테우스 디지털 헬스, 인코포레이티드 | Electromagnetic detection and detection of ingestible event markers |
US20180035909A1 (en) * | 2016-08-04 | 2018-02-08 | Cardiac Insight, Inc. | Ambulatory heart monitor with conductive adhesive connection to electronics module |
JP6907326B2 (en) * | 2016-10-17 | 2021-07-21 | マイクロメッド・カンパニー・リミテッドMicroMED Co., Ltd. | Micro delivery device |
US20200054285A1 (en) * | 2016-10-31 | 2020-02-20 | Brain Sentinel, Inc. | Electrode Patch |
WO2018101786A1 (en) * | 2016-12-02 | 2018-06-07 | 주식회사 바이랩 | Electrode belt device for measuring bio-signal |
JP2018143367A (en) * | 2017-03-02 | 2018-09-20 | オムロンヘルスケア株式会社 | Low-frequency therapeutic instrument, body for low-frequency therapeutic instrument, and combination of pad and holder for low-frequency therapeutic instrument |
CN110913759A (en) * | 2017-03-08 | 2020-03-24 | 门塔拉布有限公司 | System for detecting biological signals |
EP3375355A1 (en) * | 2017-03-17 | 2018-09-19 | bluepoint medical GmbH & Co. KG | Assembly and method for pulse oximetry and use |
JP7033469B2 (en) * | 2017-04-28 | 2022-03-10 | 日東電工株式会社 | Biosensor |
USD837394S1 (en) | 2017-07-11 | 2019-01-01 | Neurometrix, Inc. | Transcutaneous electrical nerve stimulation (TENS) device |
US20190059757A1 (en) * | 2017-08-31 | 2019-02-28 | Medicomp, Inc. | Pendant physiological signal monitor and associated systems and methods |
USD857910S1 (en) | 2017-09-21 | 2019-08-27 | Neurometrix, Inc. | Transcutaneous electrical nerve stimulation device |
USD865986S1 (en) | 2017-09-21 | 2019-11-05 | Neurometrix, Inc. | Transcutaneous electrical nerve stimulation device strap |
WO2019074787A1 (en) | 2017-10-09 | 2019-04-18 | The Joan and Irwin Jacobs Technion-Cornell Institute | Systems, apparatus, and methods for detection and monitoring of chronic sleep disorders |
EP3700407A1 (en) | 2017-10-27 | 2020-09-02 | Roche Diabetes Care GmbH | A device and a method for detecting at least one analyte in a body fluid of a user |
US11406525B2 (en) | 2017-11-09 | 2022-08-09 | 11 Health And Technologies Limited | Ostomy monitoring system and method |
CN110063713A (en) * | 2018-01-24 | 2019-07-30 | 伟伦公司 | Physiological parameter monitor with fixing seat and the EM equipment module that can be removably attaching in fixing seat |
USD861903S1 (en) | 2018-05-15 | 2019-10-01 | Neurometrix, Inc. | Apparatus for transcutaneous electrical nerve stimulation |
US20200100696A1 (en) * | 2018-10-01 | 2020-04-02 | Welch Allyn, Inc | Physiological Parameter Monitor with a Cleat and an Equipment Module Removably Attachable to the Cleat |
USD893514S1 (en) | 2018-11-08 | 2020-08-18 | 11 Health And Technologies Limited | Display screen or portion thereof with graphical user interface |
US20220015681A1 (en) | 2018-11-11 | 2022-01-20 | Biobeat Technologies Ltd. | Wearable apparatus and method for monitoring medical properties |
CN113543698A (en) * | 2018-12-13 | 2021-10-22 | 武汉联影智融医疗科技有限公司 | Apparatus, system and method for user monitoring using electronic skin |
US11051757B2 (en) * | 2019-01-31 | 2021-07-06 | Preventice Technologies, Inc. | Self-aligning device to patch interface |
US20200329983A1 (en) | 2019-04-17 | 2020-10-22 | Masimo Corporation | Liquid inhibiting air intake for blood pressure monitor |
US11668686B1 (en) | 2019-06-17 | 2023-06-06 | Flex Ltd. | Batteryless architecture for color detection in smart labels |
US11696681B2 (en) | 2019-07-03 | 2023-07-11 | Bardy Diagnostics Inc. | Configurable hardware platform for physiological monitoring of a living body |
US11096579B2 (en) | 2019-07-03 | 2021-08-24 | Bardy Diagnostics, Inc. | System and method for remote ECG data streaming in real-time |
US11116451B2 (en) | 2019-07-03 | 2021-09-14 | Bardy Diagnostics, Inc. | Subcutaneous P-wave centric insertable cardiac monitor with energy harvesting capabilities |
USD919100S1 (en) | 2019-08-16 | 2021-05-11 | Masimo Corporation | Holder for a patient monitor |
USD985498S1 (en) | 2019-08-16 | 2023-05-09 | Masimo Corporation | Connector |
USD917704S1 (en) | 2019-08-16 | 2021-04-27 | Masimo Corporation | Patient monitor |
USD921202S1 (en) | 2019-08-16 | 2021-06-01 | Masimo Corporation | Holder for a blood pressure device |
USD919094S1 (en) | 2019-08-16 | 2021-05-11 | Masimo Corporation | Blood pressure device |
EP4021293A4 (en) | 2019-08-28 | 2023-08-09 | Rds | Vital signs or health monitoring systems and methods |
USD927699S1 (en) | 2019-10-18 | 2021-08-10 | Masimo Corporation | Electrode pad |
CN111110233B (en) * | 2019-12-24 | 2022-10-11 | 浙江清华柔性电子技术研究院 | Multi-interface flexible electrode |
CN113057642A (en) * | 2019-12-31 | 2021-07-02 | 吴智良 | Physiological signal monitoring device |
US11083371B1 (en) | 2020-02-12 | 2021-08-10 | Irhythm Technologies, Inc. | Methods and systems for processing data via an executable file on a monitor to reduce the dimensionality of the data and encrypting the data being transmitted over the wireless network |
AU2021259237A1 (en) * | 2020-02-21 | 2022-10-13 | Christopher Brown | Microneedle array sensor patch for continuous multi-analyte detection |
USD933232S1 (en) | 2020-05-11 | 2021-10-12 | Masimo Corporation | Blood pressure monitor |
GB2596268B (en) * | 2020-04-20 | 2024-03-27 | Prevayl Innovations Ltd | Assembly, article and method of making the same |
US11744501B2 (en) | 2020-05-07 | 2023-09-05 | GE Precision Healthcare LLC | Multi-sensor patch |
USD979516S1 (en) | 2020-05-11 | 2023-02-28 | Masimo Corporation | Connector |
WO2022032118A1 (en) | 2020-08-06 | 2022-02-10 | Irhythm Technologies, Inc. | Electrical components for physiological monitoring device |
CN116322497A (en) | 2020-08-06 | 2023-06-23 | 意锐瑟科技公司 | Viscous physiological monitoring device |
FR3121596A1 (en) * | 2021-04-09 | 2022-10-14 | Pkvitality | Body monitoring device comprising improved electrical contacts |
DK202170259A1 (en) * | 2021-05-20 | 2022-12-12 | Nile Ab | A monitoring device and a data collector assembly |
USD987657S1 (en) | 2021-06-15 | 2023-05-30 | Wesper Inc. | Display screen with animated graphical user interface |
US20230190162A1 (en) * | 2021-12-20 | 2023-06-22 | GE Precision Healthcare LLC | Surface electrode for patient monitoring |
US20230355153A1 (en) * | 2022-05-03 | 2023-11-09 | Bittium Biosignals Oy | Bio-signal apparatus, operation method of bio-signal apparatus and manufacturing method of bio-signal apparatus |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5249576A (en) * | 1991-10-24 | 1993-10-05 | Boc Health Care, Inc. | Universal pulse oximeter probe |
US6435882B1 (en) * | 2001-07-27 | 2002-08-20 | Agilent Technologies, Inc. | Socketable flexible circuit based electronic device module and a socket for the same |
US20030216662A1 (en) * | 2002-01-25 | 2003-11-20 | Inotech Medical Systems, Inc. | Film barrier dressing for intravascular tissue monitoring system |
Family Cites Families (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS57112846A (en) * | 1980-12-31 | 1982-07-14 | Norio Akamatsu | Electrocardiograph meter |
US5465715A (en) * | 1993-08-13 | 1995-11-14 | Ludlow Corporation | Positive locking biomedical electrode and connector system |
US5458124A (en) | 1994-02-08 | 1995-10-17 | Stanko; Bruce E. | Electrocardiographic signal monitoring system |
US6327487B1 (en) * | 1995-05-04 | 2001-12-04 | Robert A. Stratbucker | Bioelectric interface |
FR2795300B1 (en) * | 1999-06-23 | 2002-01-04 | Ela Medical Sa | HOLTER APPARATUS FOR RECORDING PHYSIOLOGICAL SIGNALS OF CARDIAC ACTIVITY |
US6636754B1 (en) * | 2000-07-10 | 2003-10-21 | Cardiodynamics International Corporation | Apparatus and method for determining cardiac output in a living subject |
US6603995B1 (en) | 2000-10-19 | 2003-08-05 | Reynolds Medical Limited | Body monitoring apparatus |
US6662056B2 (en) * | 2000-12-22 | 2003-12-09 | Koninklijke Philips Electronics N.V. | Cartridge for storing an electrode pad |
US6935889B2 (en) * | 2001-02-28 | 2005-08-30 | Koninklijke Philips Electronics N.V. | Electrode-pad package that is removable from an electrode-pad lead and method for opening the package |
US20030028219A1 (en) * | 2001-07-20 | 2003-02-06 | Powers Daniel J. | Modular medical device, base unit and module thereof, and automated external defibrillator (AED), methods for assembling and using the AED |
US7139615B2 (en) * | 2001-10-31 | 2006-11-21 | Koninklijke Philips Electronics, N.V. | Single separable electrode and self-contained pad viability tester |
GB2394294A (en) * | 2002-10-18 | 2004-04-21 | Cambridge Neurotechnology Ltd | Cardiac sensor with accelerometer |
US7083480B2 (en) * | 2002-12-20 | 2006-08-01 | Koninklijke Philips Electronics N.V. | Double connector for medical sensor |
US20040214478A1 (en) * | 2003-04-24 | 2004-10-28 | Inovise Medical, Inc. | Coupler-adapeter for electrical amd audio anatomical signal sensor |
-
2006
- 2006-10-30 JP JP2008542870A patent/JP2009517160A/en active Pending
- 2006-10-30 EP EP06821260.4A patent/EP1956973B1/en active Active
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- 2006-10-30 US US12/094,272 patent/US20080288026A1/en not_active Abandoned
- 2006-10-30 CN CN2006800450473A patent/CN101321494B/en active Active
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5249576A (en) * | 1991-10-24 | 1993-10-05 | Boc Health Care, Inc. | Universal pulse oximeter probe |
US6435882B1 (en) * | 2001-07-27 | 2002-08-20 | Agilent Technologies, Inc. | Socketable flexible circuit based electronic device module and a socket for the same |
US20030216662A1 (en) * | 2002-01-25 | 2003-11-20 | Inotech Medical Systems, Inc. | Film barrier dressing for intravascular tissue monitoring system |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2024015381A1 (en) * | 2022-07-11 | 2024-01-18 | Abbott Diabetes Care Inc. | Systems, devices, and methods for analyte monitoring |
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WO2007063436A1 (en) | 2007-06-07 |
JP2009517160A (en) | 2009-04-30 |
EP1956973A1 (en) | 2008-08-20 |
US20080288026A1 (en) | 2008-11-20 |
CN101321494A (en) | 2008-12-10 |
CN101321494B (en) | 2011-04-06 |
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